Mr. Charles L. Voellinger
- Nomax Inc
9735 Green Park Industrial Drive
Saint Louis, MO 63123-7241
- Issuing Office:
- Kansas City District Office
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Kansas City District Office
8050 Marshall Drive – Suite 205
Lenexa, KS 66214
December 15, 2016
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
CMS Case: 512566
Charles L. Voellinger, President/CEO
9735 Green Park Industrial Dr.
Saint Louis, MO 63123-7241
Dear Mr. Voellinger:
During an inspection of your firm located in St. Louis, MO, on October 18-27, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer/repacker of drugs, devices, food and supplement products. Specifically, your firm manufactures/repackages devices such as: contact lens cases (class II device), and Red Cote Disclosing tablets (class II device). 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 any function of the body.
This inspection revealed that your firm's 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 (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
The inspection revealed the following significant violations including:
1) Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary, as required by 21 CFR 820.198(c).
A. You failed to review, evaluate, and investigate quality complaints involving a class II device (Pink and Green FlatPacks: a container for soft, gas permeable and hard contact lenses case used during chemical disinfection and storage) bleeding into contact lenses (discoloring the contact lenses).
Customer Relationship Manager (CRM) (b)(4)
quality complaint reports for Class II
devices are not reviewed by your Quality Department.
2) Corrective and preventive action activities and/or results have not been adequately documented as required by 21 CFR 820.100(b).
Your firm failed to verify or validate the corrective and preventive action to ensure such action is effective and does not adversely affect the finished product. Your firm (b)(4) for Red Cote Disclosing solution when the pH was out of specification for lot 10140, in June of 2016, without documenting adequate effectiveness verification.
3) The results and/or dates of management reviews are not documented as required by 21 CFR 820.20(c).
You failed to review and document the suitability and effectiveness of the quality system at defined intervals. The dates and results of management review meetings, including a list of attendees and review of quality trend analyses, were not documented from January 2015 to September 2016.
4) Acceptance activities were not adequately documented as required by 21 CFR 820.80(e).
You failed to document acceptance activities for a class II device - FlatPacks: a container for soft, gas permeable and hard contact lenses used during chemical disinfection and storage, lot no. A-01410, received on 10/10/2016. The results of the device specifications such as width, depth of cup and cup diameter were not documented to confirm the device conforms to specifications.
5) A device history record has not been maintained as required by 21 CFR 820.184.
You failed to maintain a Device History Record (DHR) for FlatPacks: a container for soft, gas permeable and hard contact lenses used during chemical disinfection and storage.
6) Potential suppliers were not evaluated based on their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1).
Your supplier of FlatPacks: a container for soft, gas permeable and hard contact lenses used during chemical disinfection and storage, a class II device, has not been evaluated to assure the supplier meets quality requirements.
We received your response dated November 17, 2016, to the observations noted on Form FDA 483, List of Inspectional Observations, issued to you at the close of our inspection. Your response will be maintained on file as a record of your firm’s efforts to correct the deficiencies noted by the investigator. A complete evaluation of the effectiveness of the actions taken will be made during the next inspection of your facility. We have concerns regarding the timeliness of training of key personnel, the gap analysis for your FlatPack product and full audit of the products manufactured and distributed by this site.
Your firm should take prompt action to correct the violations addressed in this letter, as well as any other violations of the Act and its implementing regulations. 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 II 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.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those 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 firm’s response should be comprehensive and address all violations included in this Warning Letter.
Please send your reply to the attention of:
Miguel Hernandez, Director, Compliance Branch
U.S. Food and Drug Administration
Kansas City District Office, 8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
If you have questions regarding this letter, please contact Mr. Eric Mueller, Compliance Officer at 402-331-8536 ext. 101 or firstname.lastname@example.org
Cheryl A. Bigham,
District Director, Kansas City District
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