Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-02.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2024 – 2 Apr 2024 | Human Drugs | 483 | View 483 → |
| 13 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | On file |
| 17 Sep 2019 – 26 Sep 2019 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 30 Oct 2018 | Human Drugs | Clean | |
| 2 Nov 2017 – 10 Nov 2017 | Human Drugs | 483 | View 483 → |
| 24 Aug 2017 – 1 Sep 2017 | Human Drugs | 483 | On file |
| 16 Mar 2015 – 24 Mar 2015 | Human Drugs | Clean | |
| 7 Mar 2013 – 15 Mar 2013 | Human Drugs | Clean | |
| 1 Feb 2011 | Not recorded | Clean | |
| 11 Jun 2010 | Not recorded | Clean | |
| 5 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Christopher R Czajka
26 Sep 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Cheryl A Clausen
26 Sep 2019
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Cheryl A Clausen
Investigators
FDA investigators tied to this site in the record.
Christopher R Czajka1 insp.
Zhihao Pete Qiu1 insp.
Cheryl A Clausen1 insp.
Laurie Nelson1 insp.
Michael A Charles1 insp.
Marion Michaelis1 insp.
Russell J Glapion1 insp.
Nancy G Schmidt1 insp.
Uttaniti Limchumroon1 insp.
Paul L Bellamy1 insp.
Ginger M Sykes1 insp.
Patricia F Hughes Troost1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chugai Pharma Manufacturing Co., Ltd's 6 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