Morishita Jintan Co. Ltd.
Form 483 issued May 19, 2023 · Tagacho, Japan
- Inspection
- May 15 – May 19, 2023
- Investigator
- Saundrea A. Munroe
- Observations
- 3
- Pages
- 3
- FEI number
- 3007328931
In short: On May 19, 2023, FDA issued a Form 483 with 3 observations to Morishita Jintan Co. Ltd. in Tagacho, Japan (FEI 3007328931) after an inspection that ran May 15 – May 19, 2023. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls and production.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The evaluation of the stability of homeopathic drug products is not based on the same container…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmMorishita Jintan 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 Morishita Jintan Co. Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Morishita Jintan Co. Ltd.?
Saundrea A. Munroe is named on this Form 483, for the inspection of May 15 – May 19, 2023. Each investigator has a profile showing what they cite most.
When was Morishita Jintan Co. Ltd. inspected by FDA?
The inspection ran May 15 – May 19, 2023, and the Form 483 is dated May 19, 2023.
How do I get the full Form 483 for Morishita Jintan 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.