McGuff Compounding Pharmacy Services, Inc.
FDA inspection history in Santa Ana, California, 2014 to 2019
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one Form 483; 2015: one warning letter; 2018: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15One Form 483 and one warning letter, at Santa Ana, California.
- 2018–19One close-out letter and one Form 483, at Santa Ana, California.
- 2019The longest 483 on file: 7 observations over 5 pages at Santa Ana, California.
Cited most
Across all McGuff Compounding Pharmacy Services observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.167Special testing requirements1
- 21 CFR 211.192Production record review1
The complete McGuff Compounding Pharmacy Services file.
All 4 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, one close-out letter and one warning letter · 2014 to 2019 · 9 observations
Latest: Form 483, Nov 22, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-22 | 483 Form 483 | Santa Ana, California | 7 | $99 |
| 2018-08-17 | Close-out Close-out letter | Santa Ana, California | — | $99 |
| 2015-11-13 | Warning letter Warning letter | Santa Ana, California | — | $99 |
| 2014-12-31 | 483 Form 483 | Santa Ana, California | 2 | $99 |
Investigators on these documents
Caryn M. McNab (1)Linda F. Murphy (1)Sangeeta M. Khurana (1)Scott N. Lim (1)
FEI number 3005031360 · most recent document Nov 22, 2019
About McGuff Compounding Pharmacy Services, Inc.
How many FDA Form 483s has McGuff Compounding Pharmacy Services, Inc. received?
FDA Intel has 2 Form 483s on file for McGuff Compounding Pharmacy Services, Inc.; the most recent is dated Nov 22, 2019.
When was McGuff Compounding Pharmacy Services, Inc. last inspected by FDA?
The most recent FDA inspection document on file for McGuff Compounding Pharmacy Services, Inc. is a Form 483 dated Nov 22, 2019, for the site in Santa Ana, California.
What did FDA cite at McGuff Compounding Pharmacy Services, Inc.?
The regulations cited most in the observations on file for McGuff Compounding Pharmacy Services, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.166 (Stability testing), 1 time.
Has McGuff Compounding Pharmacy Services, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for McGuff Compounding Pharmacy Services, Inc.; the most recent is dated Nov 13, 2015.