# FDA 483 - Medsource, Inc. - March 31, 2015

Source: https://www.globalkeysolutions.net/records/483/medsource-inc/774e7ffb-fa37-4852-8785-a3b4fdcc141c

> FDA 483 for Medsource, Inc. on March 31, 2015. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medsource, Inc.
- Inspection Date: 2015-03-31
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Medsource, Inc. in Tiverton, RI, a manufacturer of HCT/Ps and medical devices, was cited for significant deficiencies across its operations. The inspection revealed a lack of critical procedures for HCT/P handling, medical device storage, and fundamental quality system elements. These issues indicate a severely underdeveloped quality management system.

## Related Documents

- [WARNING_LETTER - 2015-03-31](https://www.globalkeysolutions.net/records/warning_letter/medsource-inc/93cde4f4-39b3-4d9a-91e3-e30f36519c91)

## Related Officers

- [Engineer/Investigator](https://www.globalkeysolutions.net/people/elizabeth-b-griffin/5567685a-c657-4710-afee-e7af8875b605)

Company: https://www.globalkeysolutions.net/companies/medsource-inc/56184a2f-6fa1-40bb-851c-83a16c5cda45

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7