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 820.30(e). Design review - documentation The design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
21 CFR 820.30(g). Design validation - documentation The results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not documented in the design history file.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.30(f). Design verification - documentation The design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification, were not documented in the design history file.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations have not been documented.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
21 CFR 830.300(a). Devices subject to device identification GUDID data submission requirements. The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
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 established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
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
Amherst, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.