Pharmakon Compounding Pharmacy Inc.
FDA inspection history in Noblesville, Indiana, 2016 to 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483 and one warning letter, at Noblesville, Indiana.
Cited most
Across all Pharmakon Compounding Pharmacy observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features4
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Pharmakon Compounding Pharmacy file.
All 2 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
Noblesville, Indiana
One warning letter and one Form 483 · 2016 to 2017 · 11 observations
Latest: Warning letter, Sep 7, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-09-07 | Warning letter Warning letter | Noblesville, Indiana | — | $99 |
| 2016-05-06 | 483 Form 483 | Noblesville, Indiana | 11 | $99 |
Investigators on these documents
FEI number 3012248018 · most recent document Sep 7, 2017
About Pharmakon Compounding Pharmacy Inc.
How many FDA Form 483s has Pharmakon Compounding Pharmacy Inc. received?
FDA Intel has 1 Form 483 on file for Pharmakon Compounding Pharmacy Inc.; the most recent is dated May 6, 2016.
When was Pharmakon Compounding Pharmacy Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pharmakon Compounding Pharmacy Inc. is a Form 483 dated May 6, 2016, for the site in Noblesville, Indiana.
What did FDA cite at Pharmakon Compounding Pharmacy Inc.?
The regulations cited most in the observations on file for Pharmakon Compounding Pharmacy Inc. are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Pharmakon Compounding Pharmacy Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmakon Compounding Pharmacy Inc.; the most recent is dated Sep 7, 2017.