Patheon Puerto Rico, Inc.
Form 483 issued May 31, 2018 · Manati, Puerto Rico
- Inspection
- May 14 – May 31, 2018
- Investigator
- Libia M. Lugo
- Observations
- 3
- Pages
- 9
- FEI number
- 3003113148
In short: On May 31, 2018, FDA issued a Form 483 with 3 observations to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran May 14 – May 31, 2018. The investigator was Libia M. Lugo. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
Filled drug product containers which are set aside and held in an unlabeled condition are not…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) 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 3 observations on this Form 483, mostly about quality system, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Patheon Puerto Rico, Inc.?
Libia M. Lugo is named on this Form 483, for the inspection of May 14 – May 31, 2018. Each investigator has a profile showing what they cite most.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran May 14 – May 31, 2018, and the Form 483 is dated May 31, 2018.
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.