Findings
1Process validation
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)). Your firm uses water as a component in your drug products. However, you failed to adequately qualify your water system to ensure that the system is operating properly and continuously producing water suitable for…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You failed to adequately test each shipment of each lot of propylene glycol for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that propylene glycol is an ingredient used in your drug products. Identity testing for propylene glycol and certain other high-risk drug components include a…
3Quality unit oversight
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 firm manufactures over-the-counter (OTC) drug products, such as cough, cold, and allergy medications. Your firm failed to establish an adequate quality unit (QU) to adequately oversee the manufacture of your drug products. For example, your…
About this record
Extracted automatically from the document US FDA published on 2024-09-24. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
