Patheon Biologics LLC
Form 483 issued August 2, 2019 · Saint Louis, Missouri
- Inspection
- Aug 2, 2019
- Observations
- 6
- Pages
- 6
- FEI number
- 3003418999
In short: On August 2, 2019, FDA issued a Form 483 with 6 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran Aug 2, 2019. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Routine calibration, inspection] and checking of equipment is not performed according to a written program designed…
This inspection in context
Questions about this 483
What did FDA find at Patheon Biologics LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
When was Patheon Biologics LLC inspected by FDA?
The inspection ran Aug 2, 2019, and the Form 483 is dated August 2, 2019.
How do I get the full Form 483 for Patheon Biologics 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.