Medsource, Inc.

FDA establishment 3003929882, Tiverton, Rhode Island, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 4
Official action indicated: 1
Last inspection ended: May 3, 2016
Warning letters: 0

Most Cited at This Site

Inspections citing each reference

21 CFR 1271.265(c)(1): Release of HCT/Ps by responsible person1
21 CFR 1271.265(a): Evaluation--microorganisms, damage1
21 CFR 1271.260(e): Storage temperatures recorded, maintained1
21 CFR 820.150(a): Storage procedures to prevent mix-ups1
21 CFR 820.20: Management responsibility1
21 CFR 820.100(a): Lack of or inadequate procedures1
21 CFR 820.80(a): Lack of or inadequate procedures - Acceptance activities1
21 CFR 1271.55(a)(3): Summary--records used to make determination1

Inspections

4 inspections, newest first

Ended	Product and area	Citations	Classification
May 3, 2016	Devices · Compliance: DevicesBiologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)
Mar 31, 2015	Biologics · Human Cellular, Tissue, and Gene TherapiesDevices · Compliance: Devices	9 cited references 21 CFR 1271.265(c)(1). Release of HCT/Ps by responsible person A responsible person did not document and date the determination that an HCT/P is available for distribution. 21 CFR 1271.265(a). Evaluation--microorganisms, damage Incoming HCT/Ps were not inspected for damage and contamination . 21 CFR 1271.260(e). Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not maintained . 21 CFR 820.150(a). Storage procedures to prevent mix-ups Procedures for controlling the storage of product in storage areas and stock rooms were not established to prevent mix-ups, damage, other adverse effects. 21 CFR 820.20. Management responsibility Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established. 21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been established. 21 CFR 1271.55(a)(3). Summary--records used to make determination After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination. 21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been established.	Official Action Indicated (OAI)
Jul 19, 2012	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)
Nov 4, 2009	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)

Identifiers

FEI number: 3003929882
FDA firm profile: Data Dashboard

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