Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-10-21.
At a glance
Inspections
1
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Oct 2016 – 21 Oct 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Oct 2016
21 CFR 58.120(b)
Protocol: approval of changes
Cited by Marcus F Yambot, Zhou Chen, Ke Zhang
21 Oct 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Marcus F Yambot, Zhou Chen, Ke Zhang
21 Oct 2016
21 CFR 58.29(b)
Personnel: summary of training, job description
Cited by Marcus F Yambot, Zhou Chen, Ke Zhang
21 Oct 2016
21 CFR 58.33(a)
Study director: follow study protocol
Cited by Marcus F Yambot, Zhou Chen, Ke Zhang
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.120(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.51 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Amphastar Laboratories Inc's 1 Form 483
Source PDFs 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