Tayca Corporation
Form 483 issued December 15, 2017 · Okayama, Japan
- Inspection
- Dec 15, 2017
- Investigators
- Jessica L. Pressley· Marcellinus D. Dordunoo
- Observations
- 9
- Pages
- 5
- FEI number
- 3002777902
In short: On December 15, 2017, FDA issued a Form 483 with 9 observations to Tayca Corporation in Okayama, Okayama (FEI 3002777902) after an inspection that ran Dec 15, 2017. The investigators were Jessica L. Pressley and Marcellinus D. Dordunoo. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.160 (4×) · 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Control Unit (QCU) opened Deviation: QC-170922-1 on 9/22/17 due to corrosion of the glass…
- 02
Your Quality Control Unit (QCU) opened Deviation: QC-170809-1 on 8/9/17 due to the occurrence of a…
- 03
Your computerized systems used for analysis in the QC Laboratory do not have…
- 04
Your firm failed to perform cleaning of the…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmTayca Corporation 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tayca Corporation?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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 Tayca Corporation?
Jessica L. Pressley and Marcellinus D. Dordunoo are named on this Form 483, for the inspection of Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Tayca Corporation inspected by FDA?
The inspection ran Dec 15, 2017, and the Form 483 is dated December 15, 2017.
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.