Patheon Manufacturing Services LLC
Form 483 issued November 18, 2016 · Greenville, North Carolina
- Inspection
- Nov 14 – Nov 18, 2016
- Investigators
- Christian Lynch· Michele L. Forster
- Observations
- 4
- Pages
- 3
- FEI number
- 1018495
In short: On November 18, 2016, FDA issued a Form 483 with 4 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran Nov 14 – Nov 18, 2016. The investigators were Christian Lynch and Michele L. Forster. Most observations concern facilities & equipment and packaging & labeling.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Validated procedures have not been established for CIP and manual cleaning of (D) (4)…
- 02
Written procedures have not been established for secondary packaging and labeling of…
- 03
Controls for testing and approval of drug product containers and closures used…
- 04
Adequate written procedures have not been established for the visual inspection program used for inspection of…
This inspection in context
Christian Lynch
4 documents · 2016–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Manufacturing Services LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Christian Lynch and Michele L. Forster are named on this Form 483, for the inspection of Nov 14 – Nov 18, 2016. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Nov 14 – Nov 18, 2016, and the Form 483 is dated November 18, 2016.
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.