McGuff Pharmaceuticals, Inc.
FDA inspection history in Santa Ana, California, 2010 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2010: one warning letter; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Santa Ana, California.
- 2019One Form 483, at Santa Ana, California.
- 2019The longest 483 on file: 7 observations over 7 pages at Santa Ana, California.
- 2024One Form 483, at Santa Ana, California.
Cited most
Across all McGuff Pharmaceuticals observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.113(b)Control of microbiological contamination1
The complete McGuff Pharmaceuticals 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
Santa Ana, California
Two Form 483s and one warning letter · 2010 to 2024 · 13 observations
Latest: Form 483, Jan 26, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-26 | 483 Form 483 | Santa Ana, California | 6 | $99 |
| 2019-03-26 | 483 Form 483 | Santa Ana, California | 7 | $99 |
| 2010-12-28 | Warning letter Warning letter | Santa Ana, California | — | $99 |
Investigators on these documents
Jennifer M. Gogley (1)Michael T. Cyrus (1)Pearl C. Ozuruigbo (1)
FEI number 2022073 · most recent document Jan 26, 2024
About McGuff Pharmaceuticals, Inc.
How many FDA Form 483s has McGuff Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for McGuff Pharmaceuticals, Inc.; the most recent is dated Jan 26, 2024.
When was McGuff Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for McGuff Pharmaceuticals, Inc. is a Form 483 dated Jan 26, 2024, for the site in Santa Ana, California.
What did FDA cite at McGuff Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for McGuff Pharmaceuticals, Inc. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has McGuff Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for McGuff Pharmaceuticals, Inc.; the most recent is dated Dec 28, 2010.