Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun
Form 483 issued September 2, 2022 · Gifa, Japan
- Inspection
- Aug 29 – Sep 2, 2022
- Investigator
- Santiago Gallardo Johnson
- Observations
- 3
- Pages
- 2
- FEI number
- 3008927877
In short: On September 2, 2022, FDA issued a Form 483 with 3 observations to Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun in Gifa, Japan (FEI 3008927877) after an inspection that ran Aug 29 – Sep 2, 2022. The investigator was Santiago Gallardo Johnson. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Quality system and packaging & labeling account for 2 of 3 observations.
Most cited: 21 CFR 211.22 (1×) · 211.125 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to have a quality unit that is independent of production and fulfills quality assurance (QA)…
- 02
Failure to exercise sufficient controls over computerized systems to prevent unauthorized printing…
- 03
Failure to properly maintain buildings and facilities used in the manufacture and storage…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmMeiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun?
FDA listed 3 observations on this Form 483, mostly about quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
How do I get the full Form 483 for Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-Gun?
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.