Patheon Puerto Rico, Inc.
Form 483 issued September 3, 2015 · Manati, Puerto Rico
- Inspection
- Aug 25 – Sep 3, 2015
- Investigators
- Cassandra L. Abellard· Doan T. Nguyen· Jose E. Melendez
- Observations
- 5
- Pages
- 5
- FEI number
- 3003113148
In short: On September 3, 2015, FDA issued a Form 483 with 5 observations to Patheon Puerto Rico, Inc. in Manati, Puerto Rico (FEI 3003113148) after an inspection that ran Aug 25 – Sep 3, 2015. The investigators were Cassandra L. Abellard, Doan T. Nguyen and Jose E. Melendez. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Quality system and materials account for 4 of 5 observations.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Complaint records are deficient in that they do not include the…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Written procedures are not followed for the receipt, identification, and storage of components, drug…
This inspection in context
Cassandra L. Abellard
6 documents · 2015–2023
Cites 211.194 (laboratory records) 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 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Puerto Rico, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Patheon Puerto Rico, Inc.?
Cassandra L. Abellard, Doan T. Nguyen and Jose E. Melendez are named on this Form 483, for the inspection of Aug 25 – Sep 3, 2015. Each investigator has a profile showing what they cite most.
When was Patheon Puerto Rico, Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 3, 2015, and the Form 483 is dated September 3, 2015.
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.