Polygen Pharmaceuticals Lie
Form 483 issued March 24, 2015 · Edgewood, New York
- Inspection
- Mar 11 – Mar 24, 2015
- Investigator
- Robert C. Horan
- Observations
- 2
- Pages
- 1
- FEI number
- 3008383084
In short: On March 24, 2015, FDA issued a Form 483 with 2 observations to Polygen Pharmaceuticals Lie in Edgewood, New York (FEI 3008383084) after an inspection that ran Mar 11 – Mar 24, 2015. The investigator was Robert C. Horan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New York.
The firmPolygen Pharmaceuticals Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Polygen Pharmaceuticals Lie?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Polygen Pharmaceuticals Lie?
Robert C. Horan is named on this Form 483, for the inspection of Mar 11 – Mar 24, 2015. Each investigator has a profile showing what they cite most.
When was Polygen Pharmaceuticals Lie inspected by FDA?
The inspection ran Mar 11 – Mar 24, 2015, and the Form 483 is dated March 24, 2015.
How do I get the full Form 483 for Polygen Pharmaceuticals Lie?
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.