Takasago International Corporation
Form 483 issued November 22, 2018 · Iwata, Japan
- Inspection
- Nov 19 – Nov 22, 2018
- Investigator
- Matthew B. Casale
- Observations
- 1
- Pages
- 1
- FEI number
- 3002808911
In short: On November 22, 2018, FDA issued a Form 483 with 1 observation to Takasago International Corporation in Iwata, Shizuoka (FEI 3002808911) after an inspection that ran Nov 19 – Nov 22, 2018. The investigator was Matthew B. Casale. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written procedures for out-of-specification investigations of active pharmaceutical ingredient intermediates do not include instructions on…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmTakasago International Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takasago International Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Takasago International Corporation?
Matthew B. Casale is named on this Form 483, for the inspection of Nov 19 – Nov 22, 2018. Each investigator has a profile showing what they cite most.
When was Takasago International Corporation inspected by FDA?
The inspection ran Nov 19 – Nov 22, 2018, and the Form 483 is dated November 22, 2018.
How do I get the full Form 483 for Takasago International Corporation?
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.