Patheon Biologics LLC

Form 483 issued January 24, 2023 · Saint Louis, Missouri

Inspection: Jan 18 – Jan 24, 2023
Observations: 8
Pages: 3
FEI number: 3003418999

In short: On January 24, 2023, FDA issued a Form 483 with 8 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran Jan 18 – Jan 24, 2023. Most observations concern facilities & equipment and production.

At a glance

Facilities & equipment and production account for 5 of 8 observations.

Facilities & equipment3

Production2

Materials1

Other2

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.56
The cleaning and preventative maintenance of the facility is inadequate to minimize contamination by…
02
21 CFR 211.100
The control of the manufacturing…
03
Your risk assessments regarding ””…
04
21 CFR 211.42
Your segregation between expired materials and materials for use in…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Patheon Biologics LLC history

All 8 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.56

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Patheon Biologics LLC?

FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.

When was Patheon Biologics LLC inspected by FDA?

The inspection ran Jan 18 – Jan 24, 2023, and the Form 483 is dated January 24, 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.