United Contact Lens 9/9/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Pacific Region|
22201 23rd Drive SE
Bothell, WA 98021-4421
September 9, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-23
Neal R. Cook
Owner and President
United Contact Lens, Inc.
19111 61st Avenue NE, Unit 5
Arlington, Washington 98223
Dear Mr. Cook:
During an inspection of your firm located in Arlington, Washington,on June 14-15, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures soft contact lenses. 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.
Our inspection revealed that your devices are misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)], in that the devices were manufactured, prepared, and propagated, compounded, or processed in an establishment not duly registered under section 510 [21 U.S.C. § 360] and were not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. As the owner or operator of an establishment that engages in the manufacturing of a medical device, you are required by law to register with the FDA and list the device(s) that you manufacture as required under section 510 of the Act [21 U.S.C. § 360] and Title 21, Code of Federal Regulations (CFR), Part 807.20(a). In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) requiring domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means, as noted in section 510(p) of the Act [21 U.S.C. 360(p)], during the period beginning October 1st and ending December 31st of each year. You can access FDA’s Internet site at http://www.access.fda.gov/oaa/
to submit your registration and listing information. Our records indicate that you have not fulfilled your annual registration and listing requirements for fiscal years 2009, 2010, and 2011.
We received a response letter from Ms. Christine A. O’Connell, General Manager, dated June 27, 2011. We reviewed Ms. O’Connell’s response and conclude that it is inadequate because a similar promise to register and list by your firm was made during the last inspection and you did not register and list with FDA in 2010. Furthermore, we sent you a letter, dated February 28, 2011, informing you of the requirement to register and list with the FDA.
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/or 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 awarding of contracts.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to Peter C. Chow, Compliance Officer, at the U.S. Food and Drug Administration, Seattle District, 22201 23rd Drive SE, Bothell, Washington 98021. If you have any questions about the content of this letter, please contact Mr. Chow at (425) 483-4766.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice (CGMP) requirements specified in the Quality System (QS) regulation found in 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain acceptance procedures to ensure that specific requirements for in-process product are met, as required by 21 CFR 820.80(c).
For example, your firm did not document ten rejections of contact lenses examined between April 14, 2011, and May 12, 2011, in the Dry Power Thickness Inspection Reject Log, Form #INS-002, as required by your procedure PM-416, titled “Dry Power and Thickness Inspection,” dated November 21, 2005.
We reviewed your firm’s response and conclude that it is inadequate. Although your firm stated that the issue was addressed with the employee and that additional training was implemented immediately, your firm did not provide any supporting documents, such as investigation and training records, to investigate the root cause of the problem and to confirm that the corrections and/or corrective actions were implemented and effective.
2. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. These activities shall be documented as required by 21 CFR 820.72(a).
For example, your firm did not document any (b)(4) calibration results for the curing oven in Form ref Cal-003 as required by your procedure PM1101A, titled “Calibration,” dated February 7, 2005.
We reviewed your firm’s response and conclude that it is inadequate. Although your firm stated that the calibration of the curing oven is being done (b)(4) and that procedure PM11011A has been changed and implemented to reflect the revised calibration schedule, your firm did not provide a copy of the revised procedure or any supporting documents, such as investigation and training records, to ascertain the root cause of why the calibration results were not documented and to confirm that the corrections and/or corrective actions were implemented and effective. Additionally, there is no assurance that the curing oven is qualified or calibrated for its intended use.
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 violation noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.
Charles M. Breen