Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Warning Letter Findings

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). You also manufacture (b)(4) drug products used to treat various conditions including (b)(4) . Our investigator observed a 2 cm x 126 cm piece of a non-sterile tape between (b)(4) below the HEPA filters and above the (b)(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)). Tablet compression rejections are established by setting the upper and lower limits of the main compression force. While your firm established reject limits and rates based on “prior manufacturing experience,” your…

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). You manufacture prescription drug products used to treat various conditions such as (b)(4) . Your cleaning procedures…