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  5. Schrofner Cosmetics Gmbh - 538117 - 12/20/2017
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Schrofner Cosmetics Gmbh MARCS-CMS 538117 —

Recipient Name
Mr. Stefan Schrofner
Schrofner Cosmetics Gmbh

Robiningstrabe 26a
5020 Salzburg

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 320-18-22
December 20, 2017
Mr. Stefan Schrofner
Schrofner Cosmetics Gmbh
Robiningstrabe 26a
Salzburg, 5020
Dear Mr. Schrofner:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Schrofner Cosmetics GmbH, at Robiningstrabe 26a, Salzburg, from July 17–19, 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 products are 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 response received on August, 8, 2017, in detail. Your response did not provide adequate corrective actions for any of the observations made during the inspection.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1.    Your firm failed to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a) and (d)).
Your firm lacked an adequate quality control unit.
You also failed to establish written procedures for numerous functions of the quality unit. For example, there were no procedures or documentation for the following manufacturing operations.
  • Process validation
  • Cleaning validation
  • Annual product quality review
  • Packaging and labeling operations
  • Line clearance
  • Calibration and use of measurement devices
  • Sampling
  • Change control
  • Deviations
  • Out-of-Specification investigations 
2.    Your firm failed to establish and follow adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)).
Your firm did not prepare any master production records or batch production records for your drug product, (b)(4). Without master batch records, you cannot assure the uniformity of your drug products from batch to batch.
3.    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 released your finished drug product, (b)(4), without testing for the identity and strength of the active ingredient, (b)(4). Without this testing you cannot determine if your drug products conformed to specifications.  
4.    Your firm failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).
Your firm failed to test incoming active pharmaceutical ingredients and other components you use in manufacturing (b)(4) to ensure that each component met specifications. You relied on your suppliers’ certificates of analysis for the identity of each incoming component without performing one specific identity test.
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 October 20, 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 Schrofner Cosmetics Gmbh, Robiningstrabe 26a, Salzburg, 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:
Chelsea Sealey
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 3010632712.
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
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