Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2025 – 21 Nov 2025 | Human Drugs | WL | View 483 → |
| 5 Nov 2019 – 7 Nov 2019 | Foods & Cosmetics | Clean | |
| 17 Oct 2019 – 25 Oct 2019 | Human Drugs | 483 | View 483 → |
| 25 Jun 2018 – 3 Jul 2018 | Human Drugs | 483 | On file |
| 8 Feb 2016 – 12 Feb 2016 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields, Nibin Varghese
21 Nov 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Anastasia M Shields, Nibin Varghese
21 Nov 2025
21 CFR 211.166(a)
Written program not followed
Cited by Anastasia M Shields, Nibin Varghese
21 Nov 2025
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Anastasia M Shields, Nibin Varghese
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Nibin Varghese1 insp.
Derek S Dealy1 insp.
Jason R Caballero1 insp.
Bonita S Chester1 insp.
Steven M Weinman1 insp.
Samantha J Bradley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sato Pharmaceutical Co., Ltd.'s 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat