Art of Beauty Company, Inc. — FDA Warning Letter Findings
US FDAPublished 2024-07-165 findingsLaboratory and QC controlsDeviation, CAPA, and investigationEquipment and facilityProcess validationMaterial and supplier control
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)). Your firm failed to adequately test hand sanitizer drug products for potential microbial contamination prior to batch release. Additionally, you failed to test your water system for microbial contamination at appropriate intervals. At the time of inspection on December 1, 2023, your water system…
2Deviation, CAPA, and investigation
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) lacked adequate oversight for the manufacture of your drug product. For example, you lacked adequate procedures describing the roles and responsibilities of the QU. You could not provide procedures for investigations…
3Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)), and your firm failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR…
4Process validation
Your firm failed to establish 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 failed to validate your manufacturing processes for your OTC drug products. Process (b)(4) validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage…
5Material 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 manufacture over-the-counter (OTC) hand sanitizer drug products. You failed to adequately test your incoming components for identity before manufacturing your OTC drug products. Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of drug…
About this record
Extracted automatically from the document US FDA published on 2024-07-16. 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.
