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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.72(b). Calibration procedures - content Calibration procedures do not include specific directions and limits for accuracy and precision.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.72(b). Calibration procedures - content Calibration procedures do not include specific directions and limits for accuracy and precision.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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
Lockport, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.