Progenies Pharmaceuticals, Inc
Form 483 issued March 20, 2020 · Somerset, New Jersey
- Inspection
- Mar 10 – Mar 20, 2020
- Investigator
- Yvins Dezan
- Observations
- 1
- Pages
- 14
- FEI number
- 3015189391
In short: On March 20, 2020, FDA issued a Form 483 with 1 observation to Progenies Pharmaceuticals, Inc in Somerset, New Jersey (FEI 3015189391) after an inspection that ran Mar 10 – Mar 20, 2020. The investigator was Yvins Dezan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmProgenies Pharmaceuticals, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Progenies Pharmaceuticals, Inc?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Progenies Pharmaceuticals, Inc?
Yvins Dezan is named on this Form 483, for the inspection of Mar 10 – Mar 20, 2020. Each investigator has a profile showing what they cite most.
When was Progenies Pharmaceuticals, Inc inspected by FDA?
The inspection ran Mar 10 – Mar 20, 2020, and the Form 483 is dated March 20, 2020.
How do I get the full Form 483 for Progenies Pharmaceuticals, 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.