Patheon Pharmaceuticals Inc.
Form 483 issued August 21, 2015 · Cincinnati, Ohio
- Inspection
- Aug 17 – Aug 21, 2015
- Observations
- 3
- Pages
- 2
- FEI number
- 1510437
In short: On August 21, 2015, FDA issued a Form 483 with 3 observations to Patheon Pharmaceuticals Inc. in Cincinnati, Ohio (FEI 1510437) after an inspection that ran Aug 17 – Aug 21, 2015. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complete records are not maintained of any modification of an established…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
PATHEON PHARMACEUTICALS Input to and output from the computer are not checked for accuracy. CONFIDENT…
This inspection in context
Questions about this 483
What did FDA find at Patheon Pharmaceuticals Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Patheon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 21, 2015, and the Form 483 is dated August 21, 2015.
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.