Mitsubishi Tanabe Pharma Factory Ltd.
Form 483 issued January 19, 2024 · Onoda, Japan
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 3
- FEI number
- 3002808316
In short: On January 19, 2024, FDA issued a Form 483 with 5 observations to Mitsubishi Tanabe Pharma Factory Ltd. in Onoda, Yamaguchi (FEI 3002808316). The investigator was Teresa I. Navas. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Your written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection…
- 04
Observation 4: scanned text, readable in the full document.
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 firmMitsubishi Tanabe Pharma Factory Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mitsubishi Tanabe Pharma Factory Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Mitsubishi Tanabe Pharma Factory Ltd.?
Teresa I. Navas is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Mitsubishi Tanabe Pharma Factory Ltd. inspected by FDA?
This Form 483 is dated January 19, 2024.
How do I get the full Form 483 for Mitsubishi Tanabe Pharma Factory 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.