Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-29.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2024 – 29 Mar 2024 | Human Drugs | 483 | On file |
| 23 Oct 2023 – 27 Oct 2023 | Human Drugs | Clean | |
| 17 Aug 2021 – 23 Aug 2021 | Human Drugs | 483 | On file |
| 28 Oct 2019 – 1 Nov 2019 | Human Drugs | Clean | |
| 2 Nov 2015 – 6 Nov 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Nov 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Angela E Glenn, Santos E Camara
Investigators
FDA investigators tied to this site in the record.
Jacek Cieslak2 insp.
Hamet M Toure1 insp.
Seneca D Toms1 insp.
Zhong Li1 insp.
Sangeeta M Khurana1 insp.
Angela E Glenn1 insp.
Santos E Camara1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chugai Pharma Manufacturing Co., Ltd's 3 Form 483s
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