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 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers and contractors were not evaluated and selected based on their ability to meet specified requirements.
21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
ISO 13485:2016 Clause 4.2.1. Quality management system documentation not adequate The quality management system documentation does not include statements of a quality policy and quality objectives and a quality manual.
21 CFR 820.35(a). Records for complaints involving failure to meet specifications not maintained Records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications were not maintained.
ISO 13485:2016 Clause 5.1. Lack of evidence for top management's commitment to QMS Top management did not provide evidence of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by communicating to the organization the importance of meeting requirements, establishing the quality policy, ensuring the quality objectives are established, conducting management reviews and ensuring the availability of resources.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained and implemented.
ISO 13485:2016 Clause 7.1. Records of risk management activities in product realization not maintained Records of risk management activities in product realization were not maintained.
21 CFR 820.50(b). Approval, inadequate purchasing data Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been approved and 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
Brooklyn, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.