The Compounding Shop
FDA inspection history across 2 sites, 2013 to 2014
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2013: two Form 483s; 2014: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14Two Form 483s and one warning letter, at St. Petersburg, Florida and St Petersburg, Florida.
- 2013The longest 483 on file: 12 observations over 10 pages at St Petersburg, Florida.
Cited most
Across all The Compounding Shop observations on file
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.192Production record review1
The complete The Compounding Shop 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
St. Petersburg, Florida
One warning letter and one Form 483 · 2013 to 2014 · 4 observations
Latest: Warning letter, Aug 12, 2014 →St Petersburg, Florida
One Form 483 · 2013 · 12 observations
Latest: Form 483, Mar 25, 2013 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-08-12 | Warning letter Warning letter | St. Petersburg, Florida | — | $99 |
| 2013-09-03 | 483 Form 483 | St. Petersburg, Florida | 4 | $99 |
| 2013-03-25 | 483 Form 483 | St Petersburg, Florida | 12 | $99 |
Investigators on these documents
Ileana Barreto-Pettit (1)Michael H. Tollon (1)Nicholas P. Diorio (1)Nicole E. Knowlton (1)
FEI number 3004668624 · most recent document Aug 12, 2014
About The Compounding Shop
How many FDA Form 483s has The Compounding Shop received?
FDA Intel has 2 Form 483s on file for The Compounding Shop; the most recent is dated Sep 3, 2013.
When was The Compounding Shop last inspected by FDA?
The most recent FDA inspection document on file for The Compounding Shop is a Form 483 dated Sep 3, 2013, for the site in St. Petersburg, Florida.
What did FDA cite at The Compounding Shop?
The regulations cited most in the observations on file for The Compounding Shop are 21 CFR 211.165(a) (Testing and release for distribution), 3 times; 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times.
Has The Compounding Shop received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for The Compounding Shop; the most recent is dated Aug 12, 2014.