Sato Pharmaceutical Co., Ltd
Form 483 issued November 21, 2025 · Hachioji, Japan
- Inspection
- Nov 13 – Nov 21, 2025
- Investigators
- Anastasia M. Shields· Nibin Varghese
- Observations
- 10
- Pages
- 10
- FEI number
- 3004055563
In short: On November 21, 2025, FDA issued a Form 483 with 10 observations to Sato Pharmaceutical Co., Ltd in Hachioji, Tokyo (FEI 3004055563) after an inspection that ran Nov 13 – Nov 21, 2025. The investigators were Anastasia M. Shields and Nibin Varghese. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 04
The quality control unit lacks the responsibility and authority to approve and…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSato Pharmaceutical Co., Ltd history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sato Pharmaceutical Co., Ltd?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Sato Pharmaceutical Co., Ltd?
Anastasia M. Shields and Nibin Varghese are named on this Form 483, for the inspection of Nov 13 – Nov 21, 2025. Each investigator has a profile showing what they cite most.
When was Sato Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Nov 13 – Nov 21, 2025, and the Form 483 is dated November 21, 2025.
How do I get the full Form 483 for Sato Pharmaceutical Co., Ltd?
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