Astellas Pharma Inc.
Form 483 issued March 5, 2019 · Takaoka, Japan
- Inspection
- Feb 25 – Mar 5, 2019
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 8
- Pages
- 8
- FEI number
- 3002807001
In short: On March 5, 2019, FDA issued a Form 483 with 8 observations to Astellas Pharma Inc. in Takaoka, Toyama (FEI 3002807001) after an inspection that ran Feb 25 – Mar 5, 2019. The investigator was Jose A. Cruz-Gonzalez. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.110(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Routine checking of mechanical equipment is not performed according to a written program designed…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAstellas Pharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astellas Pharma Inc.?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Astellas Pharma Inc.?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of Feb 25 – Mar 5, 2019. Each investigator has a profile showing what they cite most.
When was Astellas Pharma Inc. inspected by FDA?
The inspection ran Feb 25 – Mar 5, 2019, and the Form 483 is dated March 5, 2019.
How do I get the full Form 483 for Astellas Pharma 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.