Custom Compounding Center
FDA inspection history in Little Rock, Arkansas, 2016 to 2020
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2016: one close-out letter; 2020: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One close-out letter, at Little Rock, Arkansas.
- 2020Two Form 483s, at Little Rock, Arkansas.
- 2020The longest 483 on file: 6 observations over 3 pages at Little Rock, Arkansas.
Cited most
Across all Custom Compounding Center observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Custom Compounding Center 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
Little Rock, Arkansas
Two Form 483s and one close-out letter · 2016 to 2020 · 7 observations
Latest: Form 483, Jun 4, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-06-04 | 483 Form 483 | Little Rock, Arkansas | 1 | $99 |
| 2020-03-30 | 483 Form 483 | Little Rock, Arkansas | 6 | $99 |
| 2016-03-16 | Close-out Close-out letter | Little Rock, Arkansas | — | $99 |
Investigators on these documents
FEI number 3002401385 · most recent document Jun 4, 2020
About Custom Compounding Center
How many FDA Form 483s has Custom Compounding Center received?
FDA Intel has 2 Form 483s on file for Custom Compounding Center; the most recent is dated Jun 4, 2020.
When was Custom Compounding Center last inspected by FDA?
The most recent FDA inspection document on file for Custom Compounding Center is a Form 483 dated Jun 4, 2020, for the site in Little Rock, Arkansas.
What did FDA cite at Custom Compounding Center?
The regulations cited most in the observations on file for Custom Compounding Center are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.166 (Stability testing), 1 time.