Patheon Manufacturing Services LLC
Form 483 issued July 17, 2018 · Greenville, North Carolina
- Investigator
- Prabhu P. Raju
- Observations
- 2
- Pages
- 2
- FEI number
- 1018495
In short: On July 17, 2018, FDA issued a Form 483 with 2 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495). The investigator was Prabhu P. Raju. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following complaint record was deficient in that it does not include the findings of…
- 02
Line Clearance Checklist Forms, Form-1284, were not included in the batch production records. There is no…
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
The firmPatheon Manufacturing Services LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Manufacturing Services LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Prabhu P. Raju is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
This Form 483 is dated July 17, 2018.
How do I get the full Form 483 for Patheon Manufacturing Services LLC?
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.