Patheon Manufacturing Services LLC
Form 483 issued September 12, 2014 · Greenville, North Carolina
- Inspection
- Sep 9 – Sep 12, 2014
- Investigators
- Rhonda Alexander· Seneca Toms· Tammara A. Stephens
- Observations
- 4
- Pages
- 2
- FEI number
- 1018495
In short: On September 12, 2014, FDA issued a Form 483 with 4 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran Sep 9 – Sep 12, 2014. The investigators were Rhonda Alexander, Seneca Toms and Tammara A. Stephens. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Test procedures relative to appropriate laboratory testing for…
This inspection in context
Rhonda Alexander
1 document · 2014
Cites 211.113 (control of microbiological contamination) 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 211.113
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, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Rhonda Alexander, Seneca Toms and Tammara A. Stephens are named on this Form 483, for the inspection of Sep 9 – Sep 12, 2014. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Sep 9 – Sep 12, 2014, and the Form 483 is dated September 12, 2014.
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.