Pharmakon Pharmaceuticals Inc.
FDA inspection history across 2 sites, 2014 to 2016
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: two Form 483s; 2015: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Three Form 483s and one warning letter, at Noblesville, Indiana and Noblesville, Michigan.
- 2016The longest 483 on file: 14 observations over 17 pages at Noblesville, Indiana.
Cited most
Across all Pharmakon Pharmaceuticals observations on file
- 21 CFR 211.42Design and construction features9
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.192Production record review2
The complete Pharmakon Pharmaceuticals file.
All 4 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
Two Form 483s and one warning letter · 2014 to 2016 · 18 observations
Latest: Form 483, Mar 16, 2016 →Noblesville, Michigan
One Form 483 · 2014 · 11 observations
Latest: Form 483, Mar 13, 2014 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-03-16 | 483 Form 483 | Noblesville, Indiana | 14 | $99 |
| 2015-05-21 | Warning letter Warning letter | Noblesville, Indiana | — | $99 |
| 2014-04-08 | 483 Form 483 | Noblesville, Indiana | 4 | $99 |
| 2014-03-13 | 483 Form 483 | Noblesville, Michigan | 11 | $99 |
Investigators on these documents
Emily J. Orban (2)Emilie Kahn (1)Gary C. Pecic (1)Lisa T. Michel (1)Meisha R. Waters (1)Sarah M. Napier (1)
FEI number 3008213711 · most recent document Mar 16, 2016
About Pharmakon Pharmaceuticals Inc.
How many FDA Form 483s has Pharmakon Pharmaceuticals Inc. received?
FDA Intel has 3 Form 483s on file for Pharmakon Pharmaceuticals Inc.; the most recent is dated Mar 16, 2016.
When was Pharmakon Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pharmakon Pharmaceuticals Inc. is a Form 483 dated Mar 16, 2016, for the site in Noblesville, Indiana.
What did FDA cite at Pharmakon Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Pharmakon Pharmaceuticals Inc. are 21 CFR 211.42 (Design and construction features), 9 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.
Has Pharmakon Pharmaceuticals Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmakon Pharmaceuticals Inc.; the most recent is dated May 21, 2015.