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 1000513707, Warwick, Rhode Island, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.184(c). Quantity released The device history record does not include the quantity of devices released for distribution.
21 CFR 820.150(a). Stock rotation, assessment before release Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate.
21 CFR 820.75(a). Documentation Process validation activities and results have not been fully documented.
21 CFR 820.184(d). Acceptance records The device history record does not include acceptance records that demonstrate the device is manufactured in accordance with the device master record.
21 CFR 820.184(c). Quantity released The device history record does not include the quantity of devices released for distribution.
21 CFR 820.181(a). DMR device specifications The device master record does not include or refer to the location of all specifications.
21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures to identify valid statistical techniques needed for certain processes have not been completed and implemented.
21 CFR 820.150(b). Procedures - receipt and dispatch Procedures were not implemented for authorizing receipt from and dispatch to storage areas and stock rooms.
21 CFR 820.90(b)(1). Documentation of disposition, justification, signature There is no documentation of the justification for use of nonconforming product.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives.
21 CFR 820.100(a)(1). Procedure for analysis of data sources The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not complete.
21 CFR 820.75(c). Process changes - review, evaluation and revalidation A validated process was not reviewed and evaluated when changes or process deviations occurred.
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 and approved according to established procedures.
21 CFR 820.150(a). Stock rotation, assessment before release Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate.
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
Warwick, Rhode Island, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.