Toshiki Pigment Company Limited
Form 483 issued October 20, 2023 · Utsunomiya-shi, Japan
- Inspection
- Oct 16 – Oct 20, 2023
- Investigator
- Norman K. Starks
- Observations
- 3
- Pages
- 2
- FEI number
- 1000476331
In short: On October 20, 2023, FDA issued a Form 483 with 3 observations to Toshiki Pigment Company Limited in Utsunomiya-shi, Tochigi (FEI 1000476331) after an inspection that ran Oct 16 – Oct 20, 2023. The investigator was Norman K. Starks. Most observations concern production.
At a glance
3 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls design to assure that the drug…
- 02
Major equipment shall be identified by a distinctive identification number or code that shall be recorded…
- 03
The batch production and control records are deficient in that they do not include documentation that…
This inspection in context
Norman K. Starks
10 documents · 2018–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmToshiki Pigment Company Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Toshiki Pigment Company Limited?
FDA listed 3 observations on this Form 483, mostly about production. The opening words of each observation are shown on this page.
Who inspected Toshiki Pigment Company Limited?
Norman K. Starks is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was Toshiki Pigment Company Limited inspected by FDA?
The inspection ran Oct 16 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
How do I get the full Form 483 for Toshiki Pigment Company Limited?
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.