Patheon Manufacturing Services LLC
Form 483 issued June 13, 2024 · Ridgefield, New Jersey
- Inspection
- Jun 4 – Jun 13, 2024
- Investigator
- Richard L. Bartlett
- Observations
- 3
- Pages
- 4
- FEI number
- 2246315
In short: On June 13, 2024, FDA issued a Form 483 with 3 observations to Patheon Manufacturing Services LLC in Ridgefield, New Jersey (FEI 2246315) after an inspection that ran Jun 4 – Jun 13, 2024. The investigator was Richard L. Bartlett. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Richard L. Bartlett
4 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPatheon Manufacturing Services LLC history
The site's inspection history, in date order.
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 Manufacturing Services LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Richard L. Bartlett is named on this Form 483, for the inspection of Jun 4 – Jun 13, 2024. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Jun 4 – Jun 13, 2024, and the Form 483 is dated June 13, 2024.
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.