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.
FDA establishment 1219165, New Bedford, Massachusetts, United States. Part of Andonian Cryogenics, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.100(a)(1). Analysis of data sources Appropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management reviews were not conducted with sufficient frequency.
21 CFR 820.198(a). Complete files maintained Complete complaint files are not maintained.
21 CFR 820.72(b)(2). Calibration documentation There is no documentation of the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date for test equipment .
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits were not conducted to verify that the quality system is effective in fulfilling your quality system objectives.
21 CFR 820.184. DHR content The device history record does not demonstrate the device is manufactured in accordance with the device master record.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organization structure is not adequate to assure that quality system requirements are fully met.
21 CFR 820.20(a). Quality policy and objectives The quality policy and objectives were not established.
21 CFR 820.20(e). Quality System Procedures Quality system procedures were not established, defined, documented, and implemented.
21 CFR 820.181(a). DMR device specifications The device master record does not include or refer to the location of all specifications.
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
New Bedford, Massachusetts, United States. Part of