Findings
1Complaint and recall handling
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to adequately investigate complaints received for the over-the-counter (OTC) drug products you manufacture. For example, A complaint for Advanced Protection SPF 30, Lot (b)(4) , reporting the “entire batch is separating.” Your investigation…
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 manufacture OTC drug products without adequate assurance of the quality of your raw materials. For example, you failed to test propylene glycol…
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)). Appropriate Control over Laboratory You failed to exercise appropriate controls over 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)). Your firm uses water as a component in your OTC drug products. Your water system is not adequately qualified, controlled, maintained, and monitored to ensure that the system is operating properly and continuously…
About this record
Extracted automatically from the document US FDA published on 2024-05-14. 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.
