System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to establish adequate 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. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)).

Passage 2

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 3

You failed to demonstrate that your **(b)(4)** system can consistently meet the minimum USP monograph specifications and that you have appropriate microbial limits suitable for drug manufacturing. For example, during 2021, your firm’s **(b)(4)** testing results for **(b)(4)** exceeded the USP criteria. In addition, your firm does not have a specification for **(b)(4)** and does not perform **(b)(4)** testing on **(b)(4)**.

Passage 4

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

Passage 5

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Passage 6

You failed to have adequate controls in place for your Fourier Transform Infrared Spectrometer (FTIR) system. For example, you did not establish unique usernames and passwords for each analyst. In addition, the audit trail function was disabled even though this Fourier Transform Infrared Spectrometer is routinely used for raw material and finished product testing.