Patheon Manufacturing Services LLC
Form 483 issued February 23, 2024 · Greenville, North Carolina
- Investigators
- Laurel A. Beer· Shafig Ahadi
- Observations
- 1
- Pages
- 2
- FEI number
- 1018495
In short: On February 23, 2024, FDA issued a Form 483 with 1 observation to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495). The investigators were Laurel A. Beer and Shafig Ahadi. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Established laboratory control mechanisms…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Manufacturing Services LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Laurel A. Beer and Shafig Ahadi are 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 February 23, 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.