글로벌 규제 모니터
2026년 6월 4주차 규제뉴스

1. 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 OTC drug products such as (b)(4) . Based on the records and information you provided, you did not demonstrate that you adequately tested each shipment of each lot of incoming (b)(4) , a component at high risk for (b)(4) contamination, prior to its use in manufacturing. This includes testing of (b)(4) used in manufacturing drug products to determine its appropriate identity. Your firm also relied on the supplier’s certificate of analysis (COA) and accepted the (b)(4) component based on your supplier’s COA without establishing the reliability of your supplier’s test analyses at appropriate intervals. The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide.

2. 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)). Based on the records and information you provided, you did not demonstrate that you have adequately qualified your (b)(4) system. Additionally, you did not demonstrate that you adequately monitor your (b)(4) system. Because you use (b)(4) from this system as a component in your drug products, you should ensure that it meets, at a minimum, the USP (b)(4) monograph testing requirements and appropriate microbial limits in light of its intended use. Further, you did not demonstrate that you have an appropriate process validation program.

3. 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). Based on the records and the information you provided, you did not demonstrate that your quality unit (QU) adequately exercises its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure: Establishment of an appropriate 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)) . Appropriate validation of your analytical methods (21CFR 211.160(b)) .