The Compounding Pharmacy of America
FDA inspection history in Knoxville, Tennessee, 2015 to 2018
- 2
- Close-outs
- 2
- Form 483s
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Response
2015: one 483 response and one Form 483; 2016: one close-out letter; 2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, two close-out letters and one 483 response, at Knoxville, Tennessee.
- 2015The longest 483 on file: 16 observations over 10 pages at Knoxville, Tennessee.
Cited most
Across all The Compounding Pharmacy of America observations on file
- 21 CFR 211.42(c)(10)Design and construction features5
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete The Compounding Pharmacy of America file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Knoxville, Tennessee
Two close-out letters, two Form 483s and one 483 response · 2015 to 2018 · 18 observations
Latest: Close-out, Nov 7, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-07 | Close-out Close-out letter | Knoxville, Tennessee | — | $99 |
| 2018-02-21 | 483 Form 483 | Knoxville, Tennessee | 2 | $99 |
| 2016-06-09 | Close-out Close-out letter | Knoxville, Tennessee | — | $99 |
| 2015-06-26 | Response 483 response | Knoxville, Tennessee | — | $199 |
| 2015-05-21 | 483 Form 483 | Knoxville, Tennessee | 16 | $99 |
Investigators on these documents
Marvin D. Jones (2)Zada L. Giles (2)Brandon C. Heitmeier (1)Patricia Schafer (1)
FEI number 3011504027 · most recent document Nov 7, 2018
About The Compounding Pharmacy of America
How many FDA Form 483s has The Compounding Pharmacy of America received?
FDA Intel has 2 Form 483s on file for The Compounding Pharmacy of America; the most recent is dated Feb 21, 2018.
When was The Compounding Pharmacy of America last inspected by FDA?
The most recent FDA inspection document on file for The Compounding Pharmacy of America is a Form 483 dated Feb 21, 2018, for the site in Knoxville, Tennessee.
What did FDA cite at The Compounding Pharmacy of America?
The regulations cited most in the observations on file for The Compounding Pharmacy of America are 21 CFR 211.42(c)(10) (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time.