Patheon Biologics LLC
Form 483 issued October 9, 2018 · Saint Louis, Missouri
- Inspection
- Oct 1 – Oct 9, 2018
- Investigators
- Ee Joslyn Brunelle· Joslyn Brunelle
- Observations
- 9
- Pages
- 4
- FEI number
- 3003418999
In short: On October 9, 2018, FDA issued a Form 483 with 9 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran Oct 1 – Oct 9, 2018. The investigators were Ee Joslyn Brunelle and Joslyn Brunelle. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and production account for 6 of 9 observations.
Most cited: 21 CFR 211.113 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cell culture operations were not conducted under controls necessary…
- 02
Monitoring and control of critical process parameter (CPP) for the (b) (4) cell culture process are…
- 03
Changeover cleaning procedure between (b) (4) cell culture operations of…
- 04
Written procedures are…
This inspection in context
Ee Joslyn Brunelle
1 document · 2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmPatheon Biologics LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Biologics LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Patheon Biologics LLC?
Ee Joslyn Brunelle and Joslyn Brunelle are named on this Form 483, for the inspection of Oct 1 – Oct 9, 2018. Each investigator has a profile showing what they cite most.
When was Patheon Biologics LLC inspected by FDA?
The inspection ran Oct 1 – Oct 9, 2018, and the Form 483 is dated October 9, 2018.
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.