Soliteint Kozmetikai KFT

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, and 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 test the over-the-counter (OTC) external analgesic drug products you manufacture under contract (i.e., **(b)(4)**, **(b)(4)**, and Asutra Relieve your pain) for identity, and strength of each active ingredient prior to release and distribution.

Passage 3

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 4

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 (21 CFR 211.100(a)).

Passage 5

Your firm failed to conduct process validations for the OTC drug products you manufacture intended for the U.S. market.