Sato Pharmaceutical Co., Ltd
FDA inspection history in Hachioji, Japan, 2017 to 2026
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2017: one warning letter; 2018: one Form 483; 2019: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s and one warning letter, at Hachioji, Japan.
- 2025–26One Form 483 and one warning letter, at Hachioji, Japan.
- 2025The longest 483 on file: 10 observations over 10 pages at Hachioji, Japan.
Cited most
Across all Sato Pharmaceutical Co. observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Sato Pharmaceutical Co. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hachioji, Japan
Three Form 483s and two warning letters · 2017 to 2026 · 22 observations
Latest: Warning letter, May 18, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-18 | Warning letter Warning letter | Hachioji, Japan | — | $99 |
| 2025-11-21 | 483 Form 483 | Hachioji, Japan | 10 | $99 |
| 2019-10-25 | 483 Form 483 | Hachioji, Japan | 8 | $99 |
| 2018-07-03 | 483 Form 483 | Hachioji, Japan | 4 | $99 |
| 2017-02-02 | Warning letter Warning letter | Hachioji, Japan | — | $99 |
Investigators on these documents
Anastasia M. Shields (1)Jason R. Caballero (1)Lata Mathew (1)Nibin Varghese (1)
FEI number 3004055563 · most recent document May 18, 2026
About Sato Pharmaceutical Co., Ltd
How many FDA Form 483s has Sato Pharmaceutical Co., Ltd received?
FDA Intel has 3 Form 483s on file for Sato Pharmaceutical Co., Ltd; the most recent is dated Nov 21, 2025.
When was Sato Pharmaceutical Co., Ltd last inspected by FDA?
The most recent FDA inspection document on file for Sato Pharmaceutical Co., Ltd is a Form 483 dated Nov 21, 2025, for the site in Hachioji, Japan.
What did FDA cite at Sato Pharmaceutical Co., Ltd?
The regulations cited most in the observations on file for Sato Pharmaceutical Co., Ltd are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166(a) (Stability testing), 2 times.
Has Sato Pharmaceutical Co., Ltd received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Sato Pharmaceutical Co., Ltd; the most recent is dated May 18, 2026.