Central Glass CO., LTD.
Form 483 issued September 15, 2023 · UBE, Japan
- Inspection
- Sep 11 – Sep 15, 2023
- Investigator
- Teresa I. Navas
- Observations
- 6
- Pages
- 5
- FEI number
- 3002806649
In short: On September 15, 2023, FDA issued a Form 483 with 6 observations to Central Glass CO., LTD. in UBE, YAMAGUCHI (FEI 3002806649) after an inspection that ran Sep 11 – Sep 15, 2023. The investigator was Teresa I. Navas. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory Controls are…
- 02
Specifications of Water used in the manufacture of APIs do not demonstrate the water is suitable…
- 03
Your cleaning procedures are…
- 04
Changes that could affect the production and control of the intermediate or API are not always…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCentral Glass CO., LTD. history
The site's inspection history, in date order.
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 Central Glass CO., LTD.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Central Glass CO., LTD.?
Teresa I. Navas is named on this Form 483, for the inspection of Sep 11 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Central Glass CO., LTD. inspected by FDA?
The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Central Glass CO., 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.