FDA Intel

Patheon Biologics LLC

Form 483 issued November 10, 2023 · Saint Louis, Missouri

Observations
6
Pages
7
FEI number
3003418999

In short: On November 10, 2023, FDA issued a Form 483 with 6 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

Observations span 4 systems, led by quality system.

Quality system2
Production1
Materials1
Facilities & equipment1
Other1

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 211.100

    Standard operating procedures and protocols are not…

  2. 02
    21 CFR 211.2221 CFR 211.192

    Quality Assurance oversight of CAPA…

  3. 03
    21 CFR 211.80

    Labeling of cGMP materials…

  4. 04
    21 CFR 211.67

    Equipment is not properly…

2 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 211.100

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Patheon Biologics LLC?

FDA listed 6 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

When was Patheon Biologics LLC inspected by FDA?

This Form 483 is dated November 10, 2023.

How do I get the full Form 483 for Patheon Biologics LLC?

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