# FDA 483 - Brigham and Women's Hospital - September 16, 2021

Source: https://www.globalkeysolutions.net/records/483/brigham-and-womens-hospital/967c0cc0-047c-4d12-a42e-aa4fb5e330af

> FDA 483 for Brigham and Women's Hospital on September 16, 2021. 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: 2021-09-16
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Brigham and Women's Hospital in Boston, MA, was inspected and cited for significant deficiencies in quality control and facility maintenance. Observations included failures to investigate environmental monitoring excursions, inadequate facilities leading to contamination, and deficiencies in OOS procedures, media fill processes, and equipment qualification. These issues indicate a systemic lack of control over critical manufacturing and quality assurance processes.

## Related Documents

- [483 - 2015-12-10](https://www.globalkeysolutions.net/records/483/brigham-and-womens-hospital/e0e81215-bd82-49c3-9aa8-a24603d6e2a6)
- [483 - 2019-08-22](https://www.globalkeysolutions.net/records/483/brigham-and-womens-hospital/64f950f6-18cb-4f91-97f5-e913648e50a0)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

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

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