Posts Tagged ‘FDA’

FDA Sends Warning Letter to California Orthopedic & Spine Device Company

Wednesday, April 11th, 2012

The FDA recently conducted an inspection of a company in California, Orthopedic Alliance, and the inspection results are posted on the FDA

site. The company was found to not be in conformity with the “current good manufacturing practice requirements of the Quality System regulation.” The violations included failure to establish and maintain procedures for implementing corrective and preventative actions and failure to establish and maintain procedures for control and distribution of the finished devices.

Here’s an excerpt of the letter:

During an inspection of your firm located in Murrieta, California, on July 20, 2011, through September 23, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures various orthopedic implant devices, including the SC Total Hip System and the SC Ceramic Ball Heads. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or they are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Mr. Arnold Neves, Jr., dated September 30, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).

For example, your firm’s General Counsel Representative stated that there was no corrective and preventive action procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that two of its employees will be attending a CAPA workshop in early October, 2011, and that the CAPA procedure will be implemented in sixty days. However, neither procedures nor additional procedural details have been submitted for our review. In addition, your firm did not provide a rationale for requiring up to sixty days to complete this corrective action.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally-designated unit, as required by 21 CFR 820.198(a).


Qnexa- Not Yet

Wednesday, April 11th, 2012

FDA regulators will take another three months to make a decision on Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.

The Food and Drug Administration pushed back its target date t

o July 17, 2012 to consider a new drug safety plan submitted by the company. Previously the agency was scheduled to make a decision by April 17. Vivus said the three-month extension is standard when companies submit additional risk management information for a drug.


Recall of Brilliant Blue G Urgent Product Recall – Immediate Action Required

Sunday, March 25th, 2012

352-622-2913 ext. 209

Jim Kilbride, RPH
Fax: 352-690-6770

March 9, 2012

Dear Physician:
Our records indicate that your office received Brilliant

Blue G compounded at Franck’s Lab. We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined. The following lots of Brilliant Blue G are suspected of fungal contamination:

Lot Number:

  • 08232011@80
  • 10132011@6
  • 10112011@82
  • 10192011@125

As a precautionary measure and to prevent any additional risk of eye infections in patients, we are recalling all Brilliant Blue G compounded by Franck’s Lab. You are requested to immediately quarantine and return to us any remaining Brilliant Blue G product you may still have. This includes ALL LOTS of Brilliant Blue G that you have received from Franck’s Pharmacy. Our accounting department will issue credit on receipt of product.

Please complete the recall response form and return the product to the address below with the postage provided. If you would like to report any adverse events, or if you would like to receive additional information regarding this product recall, please contact us Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209 and request the Pharmacist-in-Charge.

Jim Kilbride, RPh
Franck’s Compounding disclaimer icon Lab
1210 SW 33rd Ave. Ocala, FL 34474
Fax: 352-690-6770

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

Sunday, March 25th, 2012

Read more: //

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally pl

aced pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

If you or anyone you know has been hurt by any pelvic mesh, call us at: 877 882 0095

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FDA Cautions On Memory, Diabetes Side Effects In Cholesterol-Lowering Drugs

Saturday, March 17th, 2012

The Food and Drug Administration just add

ed new language telling consumers about potential memory problems and an increased risk of high blood sugar for patients on statin cholesterol-lowering medicines. These medicines, including Lipitor, Zocor, and Crestor, are the most-prescribed class of drug in the country. According to drug data firm IMS Health, 255 million prescriptions for cholesterol-lowering drugs were written in 2010.

According to the FDA, the changes to the statin labels are:

* The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.

* Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.

* Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.

* Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.

If you or anyone you know has been hurt by Lipitor, Zocor or Crestor; call us at 877 882 0095

For original article see: //

Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks

Monday, March 5th, 2012

February, 2012 – (GLOBE NEWSWIRE) — Regeneca, Inc. (Pink Sheets:RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through in

dependent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

If you or anyone you know has been hurt by any Regeneca, inc product, call us at: 877 882 0095

For original article see: //

FDA Issues Warning to NY Drugmaker

Saturday, March 3rd, 2012

From a Buffalo news source:

APP Pharmaceuticals has received a warning letter from the Food and Drug Administration.

The letter notified the Staley Road manufacturer that the FDA expects it to “undertake a comprehensive and global assessmen

t” of its operations, particularly its “aseptic processing capabilities.”

The FDA inspected the plant in July, citing several “significant violations,” including insects found in vials of finished product, products with missing labels, a failure to follow quality- control procedures and improper investigating of customer complaints.

The latest letter says APP failed to properly address or correct the violations in its July response to the inspection. A statement from APP’s board of management said that the company has “full confidence” in its products’ quality and that it expects to respond satisfactorily to the FDA’s concerns.

The warning letter also said APP is manufacturing certain prescription drugs without an approved application. APP said the five drugs in question were “grandfathered,” or on the market long enough not to require FDA approval prior to 2006.

If you or anyone you know has been hurt by any APP Pharmaceutical products call us at: 877 882 0095

Source: //

FDA to look into safety of caffeine inhalers

Monday, February 20th, 2012

Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-si

ze canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

AeroShot went on the market late last month in Massachusetts and New York, and it’s also available in France. Consumers put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly.

Each grey-and-yellow plastic canister contains B vitamins, plus 100 milligrams of caffeine powder, about the equivalent of the caffeine in a large cup of coffee.

AeroShot inventor, Harvard biomedical engineering professor David Edwards, says the product is safe and doesn’t contain taurine and other common additives used to enhance the caffeine effect in energy drinks.

AeroShot didn’t require FDA review before hitting the U.S. market because it’s sold as a dietary supplement. But Sen. Charles Schumer, D-N.Y., said he met with FDA Commissioner Dr. Margaret Hamburg and she agreed to review the safety and legality of AeroShot.

“I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession,” Schumer said.

Tom Hadfield, chief executive of Breathable Foods, which makes AeroShot in France, said in a statement that the company will cooperate fully with the FDA’s review to address the issues raised by Schumer and is confident it will conclude that AeroShot is a safe, effective product that complies with FDA regulations.

The company said that when used according to its label, AeroShot provides a safe amount of caffeine and B vitamins and does not contain common additives used to enhance the effect of caffeine in energy drinks.

It said each AeroShot is not recommended for those younger than 18 and is not marketed to children.

Meanwhile, an FDA official who was at the meeting confirmed the decision, telling The Associated Press that the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product will also be tested to figure out whether it’s safe for consumption, the official said.

The official spoke on the condition of anonymity because that official was not authorized to discuss the matter.

For original article see: //,0,1259570.story

If you or anyone you know has been hurt by the Caffeine Inhaler, call us at: 877 882 0095

FDA reiterates concerns with diet pill as drugmaker prepares to make second push for approval

Friday, February 17th, 2012

Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug’s safety next week.

Vivus, based in Moun

tain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA had rejected the diet pill Qnexa in October 2010. Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable ruling.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

For original article see: //

FDA Shuts Down NJ Dental Company

Wednesday, February 15th, 2012

The Food and Drug Administration says a court order against Accurate Set requires the company to discontinue operations until the agency has verified its dental implants meet federal standards.

Accurate Set Inc., of Newark, N.J., and the com

pany’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

Under the terms of the consent decree, Accurate Set must discontinue its operations until the U. S. Food and Drug Administration clears or approves its products, which include a variety of restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA’s quality standards.

“The FDA has very clear requirements for the clearance, approval, and production of medical devices,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA’s most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.

Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.
Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices. The consent decree also requires them to comply with the QS regulation for all their devices and to retain an independent expert to inspect their operations and certify to the FDA that the necessary corrections have been made.

“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs.

In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree’s provisions.


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