Patheon Puerto Rico, Inc.
Form 483 issued July 12, 2022 · Manati, Puerto Rico
- Inspection
- Jul 5 – Jul 12, 2022
- Investigator
- Angelica M. Hernandez
- Observations
- 2
- Pages
- 5
- FEI number
- 3003113148
In short: On July 12, 2022, FDA issued a Form 483 with 2 observations to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran Jul 5 – Jul 12, 2022. The investigator was Angelica M. Hernandez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100(b) (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Puerto Rico, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Patheon Puerto Rico, Inc.?
Angelica M. Hernandez is named on this Form 483, for the inspection of Jul 5 – Jul 12, 2022. Each investigator has a profile showing what they cite most.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran Jul 5 – Jul 12, 2022, and the Form 483 is dated July 12, 2022.
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.