Patheon Manufacturing Services LLC
Form 483 issued December 17, 2015 · Greenville, North Carolina
- Inspection
- Dec 14 – Dec 17, 2015
- Observations
- 3
- Pages
- 3
- FEI number
- 1018495
In short: On December 17, 2015, FDA issued a Form 483 with 3 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran Dec 14 – Dec 17, 2015. Most observations concern production and materials.
At a glance
Production and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 02
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
- 03
Established laboratory control mechanisms are not followed and documented at…
This inspection in context
Questions about this 483
What did FDA find at Patheon Manufacturing Services LLC?
FDA listed 3 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Dec 14 – Dec 17, 2015, and the Form 483 is dated December 17, 2015.
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.