# Brigham and Women's Hospital – FDA 483, Jun 22, 2026

Source: https://www.keypedia.com/records/483/brigham-and-womens-hospital/303bf654-bf79-4445-8d7d-16d1ad89239b

> FDA 483 for Brigham and Women's Hospital on June 22, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brigham and Women's Hospital
- Inspection Date: 2026-06-22
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Brigham and Women's Hospital, Inc., The, a Positron Emission Tomography Drug Manufacturer in Boston, MA, revealed an issue with facility adequacy. Specifically, an insect was found in an ISO-7 classified cleanroom, raising concerns about potential contamination of equipment or product. This indicates a moderate severity issue related to environmental control in a sterile manufacturing environment.

## Related Documents

- [483 - 2021-09-16](https://www.keypedia.com/records/483/brigham-and-womens-hospital/967c0cc0-047c-4d12-a42e-aa4fb5e330af) — date: September 16, 2021
- [483 - 2019-08-22](https://www.keypedia.com/records/483/brigham-and-womens-hospital/64f950f6-18cb-4f91-97f5-e913648e50a0) — date: August 22, 2019
- [483 - 2015-12-10](https://www.keypedia.com/records/483/brigham-and-womens-hospital/e0e81215-bd82-49c3-9aa8-a24603d6e2a6) — date: December 10, 2015

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)
- [Sean R. Marcissin](https://www.keypedia.com/people/sean-r-marcissin/3cee7868-b7ea-477b-add3-218b9e7c5285)

Company: https://www.keypedia.com/companies/brigham-and-womens-hospital/b4f9a511-289b-4ec1-9b75-a783b3763c96

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144