Findings
1Equipment and facility
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your firm uses (b)(4) water as a component to manufacture your OTC drug product. You failed to adequately design your (b)(4) water system to ensure that it was suitable for producing water used in the…
2Stability and storage
Your firm failed to establish and follow an adequate 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)). You did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their assigned…
3Laboratory and QC controls
Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)) You failed to perform adequate release testing for each batch of your drug product prior to distribution. For example, your firm released multiple batches of your OTC SPF sunscreen drug product to the U.S. market without performing growth promotion testing on the media used for finished product…
4Quality 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 quality unit (QU) failed to ensure adequate control over CGMP records. For example, your QU failed to ensure there are adequate controls in place to assure that changes to CGMP records can be made only by authorized personnel, as employees…
5Process 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 contract manufactures over-the-counter (OTC) sun protection factor (SPF) ultraviolet (UV) sunscreen protection drug product. You failed to provide data to demonstrate that you have adequately validated…
About this record
Extracted automatically from the document US FDA published on 2024-06-18. 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.
