TAYCA CORPORATION
Form 483 issued December 1, 2023 · Akaiwa, Japan
- Inspection
- Nov 27 – Dec 1, 2023
- Investigator
- Erik W. Koester
- Observations
- 1
- Pages
- 1
- FEI number
- 3010164598
In short: On December 1, 2023, FDA issued a Form 483 with 1 observation to TAYCA CORPORATION in Akaiwa, Okayama (FEI 3010164598) after an inspection that ran Nov 27 – Dec 1, 2023. The investigator was Erik W. Koester. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm's cleaning validation was inadequate in that the firm does not verify the effectiveness of…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmTAYCA CORPORATION 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 TAYCA CORPORATION?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected TAYCA CORPORATION?
Erik W. Koester is named on this Form 483, for the inspection of Nov 27 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was TAYCA CORPORATION inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for TAYCA 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.