Patheon Pharmaceuticals Inc.
Form 483 issued February 14, 2018 · Cincinnati, Ohio
- Inspection
- Feb 5 – Feb 14, 2018
- Investigator
- Nicholas L. Paulin
- Observations
- 6
- Pages
- 8
- FEI number
- 1510437
In short: On February 14, 2018, FDA issued a Form 483 with 6 observations to Patheon Pharmaceuticals Inc. in Cincinnati, Ohio (FEI 1510437) after an inspection that ran Feb 5 – Feb 14, 2018. The investigator was Nicholas L. Paulin. Most observations concern facilities & equipment and production.
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Routine calibration of automatic equipment is not performed according to a written program designed…
This inspection in context
Nicholas L. Paulin
7 documents · 2009–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmPatheon Pharmaceuticals Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Pharmaceuticals Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Patheon Pharmaceuticals Inc.?
Nicholas L. Paulin is named on this Form 483, for the inspection of Feb 5 – Feb 14, 2018. Each investigator has a profile showing what they cite most.
When was Patheon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Feb 5 – Feb 14, 2018, and the Form 483 is dated February 14, 2018.
How do I get the full Form 483 for Patheon Pharmaceuticals 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.