Category: recalls

FDA Issues Warning Letter to CooperVision, Inc.

I have been reporting on problems with CooperVision’s contact lenses – and their drawn-out recall process – since August 23, 2011. More than 50 eFoodAlert readers have responded to my articles by describing their own unhappy experiences with several of CooperVision’s contact lens brands.

Despite all of the adverse reactions reported to FDA and those posted on eFoodAlert, CooperVision has elected NOT to recall any contact lenses other than the Avaira® Toric and Avaira® Sphere brands (and the related brand names used in various international markets).

Earlier today, FDA released a Warning Letter (Warning Letter NYK-2012-4) that the agency issued to CooperVision, Inc. on December 5, 2011. The Warning Letter resulted from an inspection of the company’s West Henrietta, NY facility and the apparent inadequacy of CooperVision’s response to significant violations noted by the FDA inspectors during their review of the company’s operations.

Following are excerpts from the FDA Warning Letter, which was addressed to Mr. John Weber, President, CooperVision, Inc (I have added emphasis of certain items in boldface).

“Dear Mr. Weber:

During an inspection of your firm located in West Henrietta, New York conducted October 14, 2011 through October 24, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device labeler, packer and distributer of daily soft wear contact lenses and extended wear soft contact lenses, Class II and Class III medical devices respectively, under the Biomedics, Proclear, Frequency, Biofinity, Avaira & Hydron names. 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 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 (CGMP) requirements of the Quality System(QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Bonnie Tsymbal, Director of Regulatory Affairs and Quality Assurance, dated November 3, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to Mr. James Della Valle, Vice President of Distribution. 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 adequately validate a process according to established procedures whose results cannot be fully verified by subsequent inspection as required by 21 C.F.R. § 820.75(a)…

2. Failure to establish procedures for finished device acceptance as required by 21 C.F.R. § 820.80(d). Specifically, your firm has not established procedures for finished device acceptance for labeling operations for any of your products…

3. Failure to establish procedures for device history records (DHR’s) as required by 21 C.F.R. § 820.184. Specifically, your firm has not established and maintained procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of this part (21 C.F.R. § 820.184)…

4. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, including failure to adequately identify the actions needed to correct and prevent recurrence of nonconforming product an other quality problems, as required by 21 C.F.R. § 820.100(a)(3). Your firm did not implement its procedure, Corrective and Preventive Action, SOP Number QAP082, Revision Number 11, for initiating a CAPA when required by its Risk Assessment Matrix. If the Risk Assessment number falls into the Red categories on the Risk Assessment Matrix, a CAPA must be raised. For its labeling operations, if a complaint or non-conforming report is categorized as a P5-mislabeled for the following reasons, then it falls into the Red category and a CAPA must be opened: incorrect human readable information on the primary packaging label, incomplete/illegible information on secondary packaging or no insert included in the secondary packaging…

5. Failure to investigate complaints involving the possible failure of labeling to meet any of its specifications as required by 21 C.F.R. § 820.198(c). Specifically, your firm did not investigate several complaints to determine a root cause for the complaint and/or the determination whether the issues described in the complaint(s) extended to other lot(s) of product…

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected…

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,
Ronald M. Pace
District Director,
New York District”

I have omitted, in the interest of brevity, the detailed examples of each of the cited failures. These can be found in the Warning Letter posted on FDA’s web site. A complete list of eFoodAlert articles about CooperVision contact lens problems can be accessed by clicking on the Toric Recalls tab at the top of the page.

Hannaford Hamburger Behind Northeast US Salmonella Outbreak

Fourteen people in the US northeast have been infected with a strain of antibiotic-resistant Salmonella Typhimurium. Eleven of the 14 victims reported having eaten ground beef; in ten cases, the beef was purchased at a Hannaford store. Seven of the 14 victims (50%) were hospitalized.

Three illnesses were reported in New Hampshire. Other outbreak victims are from Maine (4), New York State (4) and Vermont (1). Three of the four New York State victims were among the seven who were hospitalized.

The outbreak has been traced epidemiologically to fresh in-store ground beef prepared in and purchased at Hannaford stores in Maine, New York, New Hampshire and Vermont between October 12 and November 20, 2011. The 85% ground beef was the most common variety associated with the outbreak.

Hannaford has recalled the following ground beef products (all package sizes) bearing Sell-by dates of Dec. 17, 2011 or earlier that were sold at the supermarket’s stores throughout Maine, Massachusetts, New Hampshire, New York and Vermont:

  • 73% Hannaford Regular Ground Beef
  • 75% Hannaford Regular Ground Beef
  • 80% Hannaford Regular Ground Beef
  • 85% Hannaford Regular Ground Beef
  • 90% Hannaford Regular Ground Beef
  • 80% Taste of Inspirations Angus Ground Beef
  • 85% Taste of Inspirations Angus Ground Beef
  • 90% Taste of Inspirations Angus Ground Beef
  • 85% Nature’s Place Ground Beef
  • 90% Nature’s Place Ground Beef

USDA’s Food Safety and Inspection Service (FSIS) has not been able to identify the suppliers who furnished Hannaford with the raw meat that was used to prepare the recalled ground beef, due to what the agency described as the retailer’s “limited records.” The possibility exists that raw beef contaminated with the Salmonella outbreak strain may also have been supplied to other retailers in the region.

Consumers who purchased ground beef from a Hannaford Supermarket should check their refrigerators and freezers for the recalled product. Hannaford is urging its customers to discard or return any packages of ground beef bearing a sell-by date of Dec. 17, 2011 or earlier. Anyone experiencing symptoms of salmonellosis should seek medical attention.

FSIS reminds consumers to “safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160° F.”

IAMS Puppy Food – This Time, It’s A Recall

On November 25th, Price Chopper (a regional supermarket chain based in the US northeast) posted a recall notice advising its customers that two IAMS pet foods were recalled due to elevated levels of aflatoxins.

During the Thanksgiving weekend, this recall notice disappeared from the Price Chopper web site. A couple of days later, the supermarket chain posted the following statement:

“Iams has not issued a consumer recall on any products. Information which appeared here earlier referred to a few production lots which Iams has retrieved because they were outside of Iams’ specifications and did not meet their quality standards.”

When I asked IAMS for details on this recall, I received this reply:

“Thank you for taking the time to contact us. We regret the confusion. Iams has not issued a consumer recall on any of our products. We are aware the retailer posted some information which led readers to believe that Iams had issued a consumer recall. The store has since removed the information from their site.”

According to Sue Thixton (TruthAboutPetFoods.com), IAMS described their action as a “product pull” that did not require consumer notification.

Today, Procter & Gamble – owner of the IAMS brand – announced a recall of Iams ProActive Health Smart Puppy Dry Dog Food, sold in 7-lb (Code date 12784177I6), 8-lb (Code dates 12794177D2 and 12794177D3) and 17.5-lb bags (Code dates 12794177K1 and 12794177K2), due to aflatoxin levels that were above the acceptable limit. The recalled products are labeled with Use By or Expiration Dates of February 5 or February 6, 2013.

The products, according to Procter & Gamble, already have been retrieved from store shelves. They were distributed to “a limited number of retailers” in Alabama, Connecticut, Delaware, Florida, Georgia, Louisiana, Maryland, Maine, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina and Virginia. The list of retailers includes Walmart, Food City, Price Chopper, Big Y and Target.

Interestingly, the 12794177D3 code date included in today’s recall is identical to one of the code dates listed in Price Chopper’s original recall notice – and associated with a Cat Food.

Procter & Gamble hasn’t explained why this particular puppy food was worthy of recall, while the aflatoxin-contaminated cat food with the identical code date only rated a “product pull.” Was it pressure from FDA? Did Walmart – a retailer with enormous clout – “encourage” the company to issue a recall notice? Or did the public reaction to the initial recall/product pull flip-flop convince Procter & Gamble to go public? We’ll never know.

Whatever triggered the recall decision, I hope that Procter & Gamble now realizes that trying to conduct a stealth recall carries a significant risk to the company’s reputation once the recall is found out.