Foshan Miwei Cosmetics Co., Ltd.

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 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. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

Passage 2

Your firm failed to adequately monitor **(b)(4)** and the microbiological quality of **(b)(4)** used as a component in drug product manufacturing. **(b)(4)** must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

Passage 3

Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 4

Your firm failed to establish an adequate stability program with data demonstrating that the drug products remain acceptable throughout the labeled expiry date. For example, you assigned **(b)(4)** expiration dates to **(b)(4)** batch **(b)(4)**, **(b)(4)** batch **(b)(4)**, and **(b)(4)** batch **(b)(4)** without initiating stability testing.

Passage 5

Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).