Inspections, Compliance, Enforcement, and Criminal Investigations
Apothecary Products, Inc. 1/5/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
January 5, 2010
VIA FEDERAL EXPRESS
Mr. Raymond G. Kostick
Apothecary Products, Inc.
5401 South Graham Road
St. Charles, Michigan 48655
Dear Mr. Kostick:
During an inspection of your firm located in St. Charles, Michigan from April 28 - June 1, 2009 and September 25 - 30, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of contact lens cases which includes the Econo-Mate Contact Lens Case, Soft Grip, Deluxe Contact Lens Case, Color-Mate Deluxe Contact Lens Case, and Travel-Mate Contact Lens Case, 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.
The inspections determined that these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product(s) may be legally marketed.
We have received your firm's response to the Form FDA 483 (FDA-483) regarding the investigator's observations noted on the FDA-483 issued at the close of the inspection on June 1, 2009. In your firm's letter, dated July 16, 2009, you provide a summary of corrective actions for FDA-483 observations 1 through 5, which are being addressed by CAPA numbers 00106, 00105, 00104, 00103, and 00102. We have determined that your response to these observations is incomplete and that additional information is necessary in order for FDA to assess the adequacy of your corrective actions. Specifically:
• Regarding CAPA 00106: For example, in your response, you state that you plan to review and amend if necessary, procedure (b)(4) Incident Review. Please submit a copy of this procedure and supporting documentation of any other corrective actions taken to address this observation.
• Regarding CAPA 00105: For example, in your response you identify a corrective action to create "(b)(4) MDR Reporting working instruction". Please submit a copy of this procedure and supporting documentation of any other corrective actions taken to address this observation.
• Regarding CAPAs 00104 and 00103:For example, in your response you identify a corrective action to update procedure (b)(4) and to "improve" and "revise" the complaint database. Please submit a copy of this procedure and supporting documentation regarding corrections to your complaint database.
• Regarding CAPA 00102: For example, in your response you identify a corrective action to review and amend, if necessary, procedure (b)(4) Manufacturing Procedure". Please submit a copy of this procedure and supporting documentation of any other corrective actions taken to address this observation.
You 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 are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrective actions will occur over time, please include a timetable for implementation of those corrections. If corrective action can not be completed within 15 working days, state the reason for the delay and the time which the corrections will be completed.
Your response should be sent to LCDR Anastasia M. Piliafas-Brown, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the content of this letter, please contact LCDR Piliafas-Brown at (313) 393-8270.
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 all applicable laws and regulations administered by the FDA.
Joann M. Givens
Cc: Ron D. Barg, President
Apothecary Products, Inc.
11750 12th Avenue South
Burnsville, MN 55337