Patheon Puerto Rico, Inc.
Form 483 issued August 11, 2014 · Manati, Puerto Rico
- Inspection
- Aug 4 – Aug 11, 2014
- Investigators
- Jose A. Cruz-Gonzalez· Miguel A. Martinez
- Observations
- 6
- Pages
- 4
- FEI number
- 3003113148
In short: On August 11, 2014, FDA issued a Form 483 with 6 observations to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran Aug 4 – Aug 11, 2014. The investigators were Jose A. Cruz-Gonzalez and Miguel A. Martinez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Puerto Rico, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Patheon Puerto Rico, Inc.?
Jose A. Cruz-Gonzalez and Miguel A. Martinez are named on this Form 483, for the inspection of Aug 4 – Aug 11, 2014. Each investigator has a profile showing what they cite most.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 11, 2014, and the Form 483 is dated August 11, 2014.
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.