Findings
1Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your firm failed to establish an adequate stability program with data from long-term or accelerated storage conditions, demonstrating that the drug products remain acceptable throughout the labeled expiry period. The stability protocol provided was an incomplete 24-month stability report for (b)(4) that lacked…
2Documentation and records
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 lacked process validation data to demonstrate that you have adequately validated the manufacturing processes for drug products. Additionally, your procedures and batch records lack parameters, such as (b)(4)…
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 is a contract manufacturer of over-the-counter (OTC) (b)(4) drug products. Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Adequate change control procedures…
About this record
Extracted automatically from the document US FDA published on 2026-02-03. 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.
