Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi — FDA Warning Letter Findings

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)). Your firm manufactures over-the-counter (OTC) drug products such as (b)(4) . You failed to perform adequate identity testing of each component lot used in the manufacture of your OTC drug products…

Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a)). Your firm did not establish an adequate ongoing stability testing program to demonstrate that your OTC drug products met established specifications for identity, strength, quality, and purity for the duration of their labeled (b)(4) shelf lives. In your response, you state that you will create a stability protocol outlining…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Adequate written records for major equipment cleaning and maintenance (21 CFR 211.182)…

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)) You failed to adequately validate your production and process controls used in the manufacture of your OTC drug products. You also lacked adequate documentation that the equipment used to manufacture and test your…