Oishi Koseido Co., Ltd.
Form 483 issued September 1, 2023 · Tosu, Japan
- Inspection
- Aug 28 – Sep 1, 2023
- Investigator
- Teresa I. Navas
- Observations
- 6
- Pages
- 4
- FEI number
- 3010166685
In short: On September 1, 2023, FDA issued a Form 483 with 6 observations to Oishi Koseido Co., Ltd. in Tosu, Saga (FEI 3010166685) after an inspection that ran Aug 28 – Sep 1, 2023. The investigator was Teresa I. Navas. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Changes to written procedures are not drafted, reviewed and approved by…
- 02
Input to and output from the computer and records or data are…
- 05
Labeling and packaging materials are not representatively sampled upon receipt and before use in packaging and…
- 06
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
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 firmOishi Koseido Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oishi Koseido Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Oishi Koseido Co., Ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Oishi Koseido Co., Ltd. inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Oishi Koseido 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.