Takeda Pharmaceuticals U.S.A., Inc.
Form 483 issued March 18, 2020 · Brooklyn Park, Minnesota
- Inspection
- Mar 9 – Mar 18, 2020
- Investigators
- Bo Chi· Eric Hales· Kristen Nickens
- Observations
- 3
- Pages
- 3
- FEI number
- 3013514239
In short: On March 18, 2020, FDA issued a Form 483 with 3 observations to Takeda Pharmaceuticals U.S.A., Inc. in Brooklyn Park, Minnesota (FEI 3013514239) after an inspection that ran Mar 9 – Mar 18, 2020. The investigators were Bo Chi, Eric Hales, Kristen Nickens and Scott A. Golladay. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning validation (VAL-0021460 Ver. 3.0, Cleaning Validation Report for Centrifuge (b) (4) for (6) (4) stack…
- 02
Quality oversight of an outsourced|/)(b) (4) performance qualification…
- 03
Standard Operation Procedures (SOPs)…
This inspection in context
Bo Chi
8 documents · 2013–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmTakeda Pharmaceuticals U.S.A., Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Pharmaceuticals U.S.A., Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Takeda Pharmaceuticals U.S.A., Inc.?
Bo Chi, Eric Hales, Kristen Nickens and Scott A. Golladay are named on this Form 483, for the inspection of Mar 9 – Mar 18, 2020. Each investigator has a profile showing what they cite most.
When was Takeda Pharmaceuticals U.S.A., Inc. inspected by FDA?
The inspection ran Mar 9 – Mar 18, 2020, and the Form 483 is dated March 18, 2020.
How do I get the full Form 483 for Takeda Pharmaceuticals U.S.A., 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.