Patheon Puerto Rico, Inc.
Form 483 issued October 15, 2019 · Manati, Puerto Rico
- Inspection
- Oct 1 – Oct 15, 2019
- Observations
- 2
- Pages
- 6
- FEI number
- 3003113148
In short: On October 15, 2019, FDA issued a Form 483 with 2 observations to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran Oct 1 – Oct 15, 2019. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Questions about this 483
What did FDA find at Patheon Puerto Rico, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran Oct 1 – Oct 15, 2019, and the Form 483 is dated October 15, 2019.
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.