Patheon Biologics LLC
Form 483 issued March 2, 2023 · Saint Louis, Missouri
- Observations
- 4
- Pages
- 7
- FEI number
- 3003418999
In short: On March 2, 2023, FDA issued a Form 483 with 4 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Laboratory controls and quality system 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
Laboratory control records are not protected to ensure they include complete data derived from all tests…
- 02
Written records of investigations are not established and followed for investigating critical deviations or the failure…
- 03
All specifications, sampling plans, and test procedures are not scientifically sound and appropriate to ensure that…
- 04
Equipment has not been designed and maintained to control contamination, including exposure to objectionable microbiological contamination…
This inspection in context
Questions about this 483
What did FDA find at Patheon Biologics LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
When was Patheon Biologics LLC inspected by FDA?
This Form 483 is dated March 2, 2023.
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.