Patheon Pharmaceuticals Inc.
Form 483 issued March 11, 2016 · Cincinnati, Ohio
- Inspection
- Mar 1 – Mar 11, 2016
- Investigators
- Christopher T. Middendorf· Lauren N. Smith
- Observations
- 2
- Pages
- 4
- FEI number
- 1510437
In short: On March 11, 2016, FDA issued a Form 483 with 2 observations to Patheon Pharmaceuticals Inc. in Cincinnati, Ohio (FEI 1510437) after an inspection that ran Mar 1 – Mar 11, 2016. The investigators were Christopher T. Middendorf and Lauren N. Smith. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Pharmaceuticals Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Patheon Pharmaceuticals Inc.?
Christopher T. Middendorf and Lauren N. Smith are named on this Form 483, for the inspection of Mar 1 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was Patheon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 1 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
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.