TITAN KOGYO ,LTD.
Form 483 issued December 8, 2023 · UBE, Japan
- Inspection
- Dec 4 – Dec 8, 2023
- Observations
- 4
- Pages
- 3
- FEI number
- 3009155994
In short: On December 8, 2023, FDA issued a Form 483 with 4 observations to TITAN KOGYO ,LTD. in UBE, YAMAGUCHI (FEI 3009155994) after an inspection that ran Dec 4 – Dec 8, 2023. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.84 (2×)
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 Production Unit utilizes critical raw materials within the manufacturing process prior to the completion…
- 02
The firm’s stability program was inadequate in that the firm’s QC Laboratory failed to utilize a…
- 03
Verification testing of the raw material supplier COA is inadequate as the firm has failed to…
- 04
Equipment and utensils utilized in the production of API for the US Market are not cleaned…
This inspection in context
Questions about this 483
What did FDA find at TITAN KOGYO ,LTD.?
FDA listed 4 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was TITAN KOGYO ,LTD. inspected by FDA?
The inspection ran Dec 4 – Dec 8, 2023, and the Form 483 is dated December 8, 2023.
How do I get the full Form 483 for TITAN KOGYO ,LTD.?
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.