Shiseido America Inc.
Form 483 issued December 3, 2024 · East Windsor, New Jersey
- Inspection
- Nov 25 – Dec 3, 2024
- Investigator
- Ankur C. Patel
- Observations
- 2
- Pages
- 3
- FEI number
- 3002653086
In short: On December 3, 2024, FDA issued a Form 483 with 2 observations to Shiseido America Inc. in East Windsor, New Jersey (FEI 3002653086) after an inspection that ran Nov 25 – Dec 3, 2024. The investigator was Ankur C. Patel. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration of equipment is not performed according to a written program designed…
- 02
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmShiseido America 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 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shiseido America Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Shiseido America Inc.?
Ankur C. Patel is named on this Form 483, for the inspection of Nov 25 – Dec 3, 2024. Each investigator has a profile showing what they cite most.
When was Shiseido America Inc. inspected by FDA?
The inspection ran Nov 25 – Dec 3, 2024, and the Form 483 is dated December 3, 2024.
How do I get the full Form 483 for Shiseido America 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.