- Delarange Cosmetics BV
- 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 320-16-36
Return Receipt Requested
September 29, 2016
Mr. Wim Van Rÿ, Owner and CEO
Delarange Cosmetics & Healthcare BV
Edisonweg 36, 3899 AZ
Zeewolde, The Netherlands
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Delarange Cosmetics & Healthcare BV at Edisonweg 36, 3899 AZ, Zeewolde, from May 30 to June 3, 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 June 21, 2016, response in detail. Your response states that since you (b)(4) drug product for the U.S. market, “and because (b)(4), we have decided to inform our client ((b)(4)) about our decision to no longer produce (b)(4) product for the U.S. market.” You also stated that you “choose not to enter into substantive discussion about the observations described.” You did not commit to any corrective actions regarding the CGMP violations observed on the inspection.
Our investigator observed specific violations, including, but not limited to, the following.
1. 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))
You stated to our investigator you did not test your finished product for assay, and that you have not established final specifications release testing of your drugs.
2. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. (21 CFR 211.22(a))
You stated to our investigator that your firm does not have a quality unit to review and approve the release of your drugs.
3. Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment. (21 CFR 211.67(b))
You manufacture (b)(4) for the U.S. market on the same equipment that you use for manufacturing other products – including (b)(4). Your failure to adequately clean equipment between products risks contaminating your drugs with other potentially toxic chemicals.
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 Delarange Cosmetics and Healthcare BV, Edisonweg 36, 3899 AZ, Zeewolde, 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, 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 3009499217.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research