Findings
1Documentation and records
Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). You failed to ensure that batch records are complete, and that all manufacturing activities and operations are recorded contemporaneously. For example, the batch record for batch (b)(4) , manufactured in December 2024, approximately 6 months before the inspection, did not contain complete…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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)). You failed to conduct adequate identity testing on incoming components used in the manufacture of your over-the-counter (OTC) drug products. For…
3Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm failed to demonstrate that your test methods were appropriate to assure that your…
4Process 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)). Inadequate Process System Validation Your firm failed to adequately validate the manufacturing process for your drug products. The validation data provided from 2017 does not include the filling and packaging of…
5Stability 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 does not have an adequate stability testing program to demonstrate that the chemical and microbiological properties of your drug products meet established specifications, and that they remain acceptable for the duration of their labeled shelf lives (b)(4) . For example, you failed to revise the SOP for…
About this record
Extracted automatically from the document US FDA published on 2026-01-06. 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.
