Patheon Puerto Rico, Inc.
Form 483 issued June 21, 2016 · Manati, Puerto Rico
- Inspection
- Jun 8 – Jun 21, 2016
- Investigator
- Vilmary Negron Rodriguez
- Observations
- 1
- Pages
- 3
- FEI number
- 3003113148
In short: On June 21, 2016, FDA issued a Form 483 with 1 observation to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran Jun 8 – Jun 21, 2016. The investigator was Vilmary Negron Rodriguez. 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 whether or not the batch…
This inspection in context
Vilmary Negron Rodriguez
6 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPatheon Puerto Rico, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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 Patheon Puerto Rico, 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 Patheon Puerto Rico, Inc.?
Vilmary Negron Rodriguez is named on this Form 483, for the inspection of Jun 8 – Jun 21, 2016. Each investigator has a profile showing what they cite most.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran Jun 8 – Jun 21, 2016, and the Form 483 is dated June 21, 2016.
How do I get the full Form 483 for Patheon Puerto Rico, 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.