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BBCOS srl MARCS-CMS 541045 —

Recipient Name
Mr. Raffaele Bertola

Via del Lavoro, 37
Loc. Cappellazzo
12062 Cherasco (CN)

Issuing Office:
Center for Drug Evaluation and Research

United States



Black HHS-Blue FDA Logo



10903 New Hampshire Avenue
Silver Spring, MD 20993 


Via UPS                                                                                 Warning Letter 320-18-11
November 29, 2017
Mr. Raffaele Bertola
Chief Executive Officer
Via del Lavoro, 37
Loc. Cappellazzo
12062 Cherasco (CN)
Dear Mr. Bertola:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, BBCOS srl at Via del Lavoro, 37 Loc. Cappellazzo, 12062 Cherasco from June 19–23, 2017.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your July 6, 2017, response in detail. You did not commit to any corrective actions regarding the CGMP violations observed during the inspection and stated that you “will not be able for the time being to comply with USA Good Manufacturing Practices for OTC pharmaceuticals,” and “will therefore immediately cease to sell and ship to USA.”
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Your firm failed to test your drug products for identity and strength of active ingredients prior to release and distribution.
2. Your firm failed to ensure the identity of components sourced from various suppliers, including your active ingredients (21 CFR 211.84(d)(1) and (2)).
You failed to test incoming active pharmaceutical ingredients (API) you use in manufacturing drug products to determine their identity, purity, strength, or other appropriate specifications. Instead, your firm released API based on certificates of analysis from your supplier without establishing the reliability of the supplier’s analysis through appropriate validation.
3. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
You have not validated the manufacturing processes for your drug products. You lack assurance that your manufacturing processes result in batch uniformity, integrity, and consistent drug quality.
4. Your firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
You stated to our investigator that you had no written stability program to support the (b)(4) expiration date of your over-the-counter (OTC) drug product.
CGMP Consultant Recommended
If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
FDA placed your firm on Import Alert 66-40 on November 27, 2017.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at BBCOS srl Via del Lavoro, 37 Loc. Cappellazzo, 12062 Cherasco (CN) into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
LT Loan Chin
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI 3006447041.
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
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