Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-17.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2023 – 17 Mar 2023 | Human Drugs | 483 | View 483 → |
| 15 Oct 2018 – 18 Oct 2018 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | Clean | |
| 18 Jul 2017 – 21 Jul 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Marian E Ramirez, Alan A Rivera
17 Mar 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marian E Ramirez, Alan A Rivera
18 Oct 2018
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Alan P Kurtzberg
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez1 insp.
Alan A Rivera1 insp.
Alan P Kurtzberg1 insp.
Sangeeta M Khurana1 insp.
Steven P Donald1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CONCORD BIOTECH LIMITED'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