Shiseido America Inc.
Form 483 issued November 1, 2018 · East Windsor, New Jersey
- Inspection
- Oct 22 – Nov 1, 2018
- Investigator
- Nancy M. Espinal
- Observations
- 3
- Pages
- 4
- FEI number
- 3002653086
In short: On November 1, 2018, FDA issued a Form 483 with 3 observations to Shiseido America Inc. in East Windsor, New Jersey (FEI 3002653086) after an inspection that ran Oct 22 – Nov 1, 2018. The investigator was Nancy M. Espinal. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shiseido America Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Shiseido America Inc.?
Nancy M. Espinal is named on this Form 483, for the inspection of Oct 22 – Nov 1, 2018. Each investigator has a profile showing what they cite most.
When was Shiseido America Inc. inspected by FDA?
The inspection ran Oct 22 – Nov 1, 2018, and the Form 483 is dated November 1, 2018.
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.