- Mappel Industria de Embalagens S.A.
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993 |
Warning Letter 320-16-32
Return Receipt Requested
September 12, 2016
Mr. Maxime d’Haussy, CEO
Mappel Industria de Embalagens, SA
Av Deputado Osvaldo Moraes E Silva 55
Diadema, Sao Paulo, 09991
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mappel Industria de Embalagens, SA at Av Deputado Osvaldo Moraes E Silva 55 Diadema, Sao Paulo, from April 11 to April 15, 2016.
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 May 31, 2016, response in detail and acknowledge receipt of your subsequent correspondence. In that response, you stated: “when Mappel began manufacturing (b)(4)-labeled products for the U.S. Market, it did not fully comprehend that such products were regulated by the FDA as OTC drugs.” You also stated: “Mappel has no intention of manufacturing OTC drug products for (b)(4) and should it decide to do so (b)(4), it will notify the FDA by filing a new drug establishment registration.”
Our investigator observed specific violations, including, but not limited to, the following.
1. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).
2. Your firm does not 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)).
3. Your firm failed to follow 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(b)).
4. Your firm failed to maintain production, control, or distribution records associated with a batch of a drug product for at least one year after the expiration date of the batch (21 CFR 211.180(a)).
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.
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. Using a consultant does not relieve your firm’s obligation to comply with CGMP. Notify this office, in writing, of the specific steps that you have taken to correct violations and prevent recurrence. Provide supporting documentation. If your firm cannot complete corrective actions, state the reasons and the date by which your firm will have completed the corrections.
Until you completely correct all violations and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Mappel Industria de Embalagens, SA Av Deputado Osvaldo Moraes E Silva 55, Diadema, Sao Paulo, 09991, Brazil 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).
Carla A. Norris
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 3010462471.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research