Abbott's Compounding Pharmacy Inc.
FDA inspection history across 2 sites, 2016 to 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483 and one warning letter, at Berkeley, California and Irvine, California.
Cited most
Across all Abbott's Compounding Pharmacy observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.167(a)Special testing requirements1
The complete Abbott's Compounding Pharmacy file.
All 2 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
Irvine, California
One warning letter · 2017
Latest: Warning letter, Apr 4, 2017 →Berkeley, California
One Form 483 · 2016 · 11 observations
Latest: Form 483, Jan 8, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-04-04 | Warning letter Warning letter | Irvine, California | — | $99 |
| 2016-01-08 | 483 Form 483 | Berkeley, California | 11 | $99 |
Investigators on these documents
FEI number 3005529620 · most recent document Apr 4, 2017
About Abbott's Compounding Pharmacy Inc.
How many FDA Form 483s has Abbott's Compounding Pharmacy Inc. received?
FDA Intel has 1 Form 483 on file for Abbott's Compounding Pharmacy Inc.; the most recent is dated Jan 8, 2016.
When was Abbott's Compounding Pharmacy Inc. last inspected by FDA?
The most recent FDA inspection document on file for Abbott's Compounding Pharmacy Inc. is a Form 483 dated Jan 8, 2016, for the site in Berkeley, California.
What did FDA cite at Abbott's Compounding Pharmacy Inc.?
The regulations cited most in the observations on file for Abbott's Compounding Pharmacy Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.137(a) (Expiration dating), 1 time.
Has Abbott's Compounding Pharmacy Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Abbott's Compounding Pharmacy Inc.; the most recent is dated Apr 4, 2017.