Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 211.80(d). Identification of Each Lot in Each Shipment Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for drug product containers and closures.
21 CFR 211.84(d)(2). Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Conroe, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.