Meiji Seika Pharmatech Co., Ltd.
Form 483 issued April 8, 2022 · Odawara, Japan
- Inspection
- Apr 4 – Apr 8, 2022
- Investigator
- Teresa I. Navas
- Observations
- 3
- Pages
- 3
- FEI number
- 3015407855
In short: On April 8, 2022, FDA issued a Form 483 with 3 observations to Meiji Seika Pharmatech Co., Ltd. in Odawara, Kanagawa (FEI 3015407855) after an inspection that ran Apr 4 – Apr 8, 2022. The investigator was Teresa I. Navas. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Input to and output from the computer and records or data are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
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 firmMeiji Seika Pharmatech Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meiji Seika Pharmatech Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Meiji Seika Pharmatech Co., Ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Apr 4 – Apr 8, 2022. Each investigator has a profile showing what they cite most.
When was Meiji Seika Pharmatech Co., Ltd. inspected by FDA?
The inspection ran Apr 4 – Apr 8, 2022, and the Form 483 is dated April 8, 2022.
How do I get the full Form 483 for Meiji Seika Pharmatech 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.