Warning letter
Brigham and Women’s Hospital Inc.: warning letter of Apr 11, 2022
FDA warning letter 623476 · Office of Pharmaceutical Quality Operations Division I
Key facts
| Reference number | 623476 |
|---|---|
| Company | Brigham and Women’s Hospital Inc. |
| Subject | CGMP/Positron Emission Tomography (PET) Drugs/Adulterated |
| Issue date | Apr 11, 2022 |
| Posted date | May 10, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations Division I |
| Product type | Drugs |
| CFR sections cited | 212, 212.20(d), 212.30(a) |
| Inspection city | Boston |
| Inspection ZIP | 02115 |
| Inspection start date | Aug 5, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: