AGC Biologics Inc.
Form 483 issued October 15, 2018 · Bothell, Washington
- Investigator
- Arie C. Menachem
- Observations
- 4
- Pages
- 3
- FEI number
- 3000209996
In short: On October 15, 2018, FDA issued a Form 483 with 4 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996). The investigator was Arie C. Menachem. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and production 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
Appropriate equipment, environmental, and production controls are not consistently used to minimize the risk of contamination…
- 02
Buildings used in the manufacture of intermediates and APIs are not consistently maintained and repaired and…
- 03
Corrective actions subsequent to investigations into deviation and out-of-specification (OOS) results…
- 04
Electronic records are used as part of the production and laboratory control system, but they do…
This inspection in context
Arie C. Menachem
5 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAGC Biologics Inc. 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 AGC Biologics Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected AGC Biologics Inc.?
Arie C. Menachem is named on this Form 483. Each investigator has a profile showing what they cite most.
When was AGC Biologics Inc. inspected by FDA?
This Form 483 is dated October 15, 2018.
How do I get the full Form 483 for AGC Biologics Inc.?
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.