Schrofner Cosmetics Gmbh – FDA Warning Letter, Jul 19, 2017

On December 20, 2017, the FDA issued a Warning Letter to Schrofner Cosmetics Gmbh following an inspection from July 17-19, 2017, at their Salzburg, Austria facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

The firm's August 8, 2017, response was deemed inadequate. Specific violations included: 1. Failure to establish an adequate quality control unit and written procedures for numerous functions, such as process validation, cleaning validation, annual product quality review, packaging/labeling, line clearance, calibration, sampling, change control, deviations, and Out-of-Specification investigations (21 CFR 211.22(a) and (d)). 2. Failure to establish and follow adequate written procedures for master production and control records, with no master or batch production records for their drug product, (b)(4), preventing assurance of batch uniformity (21 CFR 211.186(a)). 3. Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications, including identity and strength of active ingredients, for finished drug product (b)(4) prior to