Findings
1Cleaning validation
Your firm failed to clean, maintain, and 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, and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b)). Your cleaning procedures were not supported…
2Equipment 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 (b)(4) water system used to manufacture drug products (e.g., Oxygenetix Institute (b)(4) ) was not designed and maintained appropriately for its intended use (i.e., cleaning, formulation). Your firm uses…
3Stability 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)). Your firm does not have adequate stability data to show that the chemical and microbiological properties of your topical acne drug products for OTC human use remain acceptable throughout the labeled expiry…
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 manufactures over-the-counter (OTC) topical acne drug products, including Oxygenetix Institute (b)(4) and Oxygenetix Institute Oxygenating Foundation Acne Control. Your acne drug product manufacturing…
5Quality 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) did not provide adequate oversight for the manufacture of your drug products. Specifically, your QU failed to ensure appropriate: Standard operating procedures Validation plans (e.g., test methods, process validations)…
About this record
Extracted automatically from the document US FDA published on 2023-12-26. 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.
