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 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.82(a). Examination on receipt, before acceptance Each container or grouping of containers of components is not examined visually upon receipt and before acceptance for container damage.
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store components at all times in a manner to prevent contamination.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Dallas, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.