South Coast Specialty Compounding, Inc.
FDA inspection history in Irvine, California, 2014 to 2017
- 3
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2016: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Three Form 483s, at Irvine, California.
- 2016The longest 483 on file: 8 observations over 9 pages at Irvine, California.
Cited most
Across all South Coast Specialty Compounding observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.28Personnel responsibilities2
The complete South Coast Specialty Compounding 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
Irvine, California
Three Form 483s · 2014 to 2017 · 18 observations
Latest: Form 483, Mar 31, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-31 | 483 Form 483 | Irvine, California | 3 | $99 |
| 2016-03-14 | 483 Form 483 | Irvine, California | 8 | $99 |
| 2014-07-02 | 483 Form 483 | Irvine, California | 7 | $99 |
Investigators on these documents
Binh T. Nguyen (1)Caryn M. McNab (1)Darren S. Brown (1)Jennifer M. Gogley (1)Roger F. Zabinski (1)Saied A. Asbagh (1)Theresa Kirkham (1)
FEI number 3003436217 · most recent document Mar 31, 2017
About South Coast Specialty Compounding, Inc.
How many FDA Form 483s has South Coast Specialty Compounding, Inc. received?
FDA Intel has 3 Form 483s on file for South Coast Specialty Compounding, Inc.; the most recent is dated Mar 31, 2017.
When was South Coast Specialty Compounding, Inc. last inspected by FDA?
The most recent FDA inspection document on file for South Coast Specialty Compounding, Inc. is a Form 483 dated Mar 31, 2017, for the site in Irvine, California.
What did FDA cite at South Coast Specialty Compounding, Inc.?
The regulations cited most in the observations on file for South Coast Specialty Compounding, Inc. are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.