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# CGMP Violations at Brigham and Women’s Hospital
- URL: https://www.fdaweb.com/cgmp-violations-at-brigham-and-womens-hospital/
- Published: 2022-05-10T12:00:00.000Z
- Updated: 2026-09-14T17:44:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151776

An 8/5-9/16/21 FDA inspection at Brigham and Women’s Hospital, Boston, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography drugs. A 4/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brigham-and-womens-hospital-inc-623476-04112022?ref=fdaweb.com) says specific violations were: 

- the facilities are not adequate to ensure the prevention of equipment or product contamination by substances, personnel, or environmental conditions that could reasonably be expected to harm product quality; and failing to follow procedures to ensure that all equipment is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results; and
- failing to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications.

The agency strongly recommends that the hospital engage a qualified consultant to assist it in meeting CGMP requirements.

Brigham and Women’s was told to promptly correct the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.