Custom Compounding Centers, LLC
FDA inspection history in Los Alamitos, California, 2012 to 2015
- 3
- Responses
- 2
- Warning letters
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Close-out
- Warning letter
- Response
- Form 483
2012: one Form 483; 2013: one warning letter; 2014: three 483 responses and one Form 483; 2015: one close-out letter and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–15Three 483 responses, two Form 483s, two warning letters and one close-out letter, at Los Alamitos, California.
- 2012The longest 483 on file: 14 observations over 5 pages at Los Alamitos, California.
Cited most
Across all Custom Compounding Centers observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.160General requirements3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166Stability testing1
The complete Custom Compounding Centers file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Los Alamitos, California
Three 483 responses, two warning letters, two Form 483s and one close-out letter · 2012 to 2015 · 17 observations
Latest: Close-out, Dec 15, 2015 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-12-15 | Close-out Close-out letter | Los Alamitos, California | — | $99 |
| 2015-12-14 | Warning letter Warning letter | Los Alamitos, California | — | $99 |
| 2014-10-17 | Response 483 response | Los Alamitos, California | — | $199 |
| 2014-10-09 | Response 483 response | Los Alamitos, California | — | $199 |
| 2014-09-18 | Response 483 response | Los Alamitos, California | — | $199 |
| 2014-08-28 | 483 Form 483 | Los Alamitos, California | 3 | $99 |
| 2013-05-15 | Warning letter Warning letter | Los Alamitos, California | — | $99 |
| 2012-12-13 | 483 Form 483 | Los Alamitos, California | 14 | $99 |
Investigators on these documents
FEI number 3009855773 · most recent document Dec 15, 2015
About Custom Compounding Centers, LLC
How many FDA Form 483s has Custom Compounding Centers, LLC received?
FDA Intel has 2 Form 483s on file for Custom Compounding Centers, LLC; the most recent is dated Aug 28, 2014.
When was Custom Compounding Centers, LLC last inspected by FDA?
The most recent FDA inspection document on file for Custom Compounding Centers, LLC is a Form 483 dated Aug 28, 2014, for the site in Los Alamitos, California.
What did FDA cite at Custom Compounding Centers, LLC?
The regulations cited most in the observations on file for Custom Compounding Centers, LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Custom Compounding Centers, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Custom Compounding Centers, LLC; the most recent is dated Dec 14, 2015.