# FDA 483 - Collaborative Laboratory Services, LLC- Saint Francis Campus - November 18, 2019

Source: https://www.globalkeysolutions.net/records/483/collaborative-laboratory-services-llc-saint-francis-campus/8bcac45c-e122-452f-b43b-d8c619b0507a

> FDA 483 for Collaborative Laboratory Services, LLC- Saint Francis Campus on November 18, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Collaborative Laboratory Services, LLC- Saint Francis Campus
- Inspection Date: 2019-11-18
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Collaborative Laboratory Services, LLC, a hospital blood bank in Hartford, CT, was cited for failing to submit required biological product deviation reports for multiple blood product events. The firm also did not consistently follow its own standard operating procedures for identifying and reporting errors to regulatory agencies. These deficiencies indicate a failure in the firm's quality system regarding deviation management and regulatory compliance.

## Related Documents

- [483 - 2025-08-20](https://www.globalkeysolutions.net/records/483/collaborative-laboratory-services-llc-saint-francis-campus/9ef1cbee-448d-4119-9f0c-f30911c33eff)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.globalkeysolutions.net/companies/collaborative-laboratory-services-llc-saint-francis-campus/522586c6-4454-48d7-96b4-772d0c9ccd16

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