Pharmagen Laboratories, Inc.
FDA inspection history across 2 sites, 2013 to 2014
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2014: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14One Form 483 and one warning letter, at Stamford, Connecticut and Silver Spring, Maryland.
Cited most
Across all Pharmagen Laboratories observations on file
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 2101
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.186(a)Master production and control records1
The complete Pharmagen Laboratories 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
Silver Spring, Maryland
One warning letter · 2014
Latest: Warning letter, Oct 24, 2014 →Stamford, Connecticut
One Form 483 · 2013 · 13 observations
Latest: Form 483, Aug 23, 2013 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-10-24 | Warning letter Warning letter | Silver Spring, Maryland | — | $99 |
| 2013-08-23 | 483 Form 483 | Stamford, Connecticut | 13 | $99 |
Investigators on these documents
FEI number 3009864179 · most recent document Oct 24, 2014
About Pharmagen Laboratories, Inc.
How many FDA Form 483s has Pharmagen Laboratories, Inc. received?
FDA Intel has 1 Form 483 on file for Pharmagen Laboratories, Inc.; the most recent is dated Aug 23, 2013.
When was Pharmagen Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pharmagen Laboratories, Inc. is a Form 483 dated Aug 23, 2013, for the site in Stamford, Connecticut.
What did FDA cite at Pharmagen Laboratories, Inc.?
The regulations cited most in the observations on file for Pharmagen Laboratories, Inc. are 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 210, 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has Pharmagen Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmagen Laboratories, Inc.; the most recent is dated Oct 24, 2014.