Pharmagen Laboratories, Inc.
Form 483 issued August 23, 2013 · Stamford, Connecticut
- Inspection
- Aug 5 – Aug 23, 2013
- Investigator
- Maya M. Davis
- Observations
- 13
- Pages
- 12
- FEI number
- 3009864179
In short: On August 23, 2013, FDA issued a Form 483 with 13 observations to Pharmagen Laboratories, Inc. in Stamford, Connecticut (FEI 3009864179) after an inspection that ran Aug 5 – Aug 23, 2013. The investigator was Maya M. Davis. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
A written record of each complaint is not maintained in a file designated for drug product…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Maya M. Davis
4 documents · 2012–2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Connecticut.
The firmPharmagen Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmagen Laboratories, Inc.?
FDA listed 13 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pharmagen Laboratories, Inc.?
Maya M. Davis is named on this Form 483, for the inspection of Aug 5 – Aug 23, 2013. Each investigator has a profile showing what they cite most.
When was Pharmagen Laboratories, Inc. inspected by FDA?
The inspection ran Aug 5 – Aug 23, 2013, and the Form 483 is dated August 23, 2013.
How do I get the full Form 483 for Pharmagen Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.