Brigham and Women's Hospital
FDA inspection history in Boston, Massachusetts, 2015 to 2022
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2015: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Boston, Massachusetts.
- 2022One warning letter, at Boston, Massachusetts.
Cited most
Across all Brigham and Women's Hospital observations on file
- 21 CFR 803.30(a)(1)If I am a user facility, what reporting requirements apply to me?2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.18(a)What are the requirements for establishing and maintaining MDR files or records that apply to me?1
The complete Brigham and Women's Hospital file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boston, Massachusetts
One warning letter, one Form 483 and one close-out letter · 2015 to 2022 · 4 observations
Latest: Warning letter, Apr 11, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-11 | Warning letter Warning letter | Boston, Massachusetts | — | $99 |
| 2015-12-10 | 483 Form 483 | Boston, Massachusetts | 4 | $99 |
| Undated | Close-out Close-out letter | Boston, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3012030543 · most recent document Apr 11, 2022
About Brigham and Women's Hospital
How many FDA Form 483s has Brigham and Women's Hospital received?
FDA Intel has 1 Form 483 on file for Brigham and Women's Hospital; the most recent is dated Dec 10, 2015.
When was Brigham and Women's Hospital last inspected by FDA?
The most recent FDA inspection document on file for Brigham and Women's Hospital is a Form 483 dated Dec 10, 2015, for the site in Boston, Massachusetts.
What did FDA cite at Brigham and Women's Hospital?
The regulations cited most in the observations on file for Brigham and Women's Hospital are 21 CFR 803.30(a)(1) (If I am a user facility, what reporting requirements apply to me?), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.18(a) (What are the requirements for establishing and maintaining MDR files or records that apply to me?), 1 time.
Has Brigham and Women's Hospital received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Brigham and Women's Hospital; the most recent is dated Apr 11, 2022.