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.