Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-04-09.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2021 – 9 Apr 2021 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Stephanie A Slater, Heidy C Perales
9 Apr 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Stephanie A Slater, Heidy C Perales
9 Apr 2021
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Stephanie A Slater, Heidy C Perales
9 Apr 2021
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Stephanie A Slater, Heidy C Perales
Investigators
FDA investigators tied to this site in the record.
Stephanie A Slater1 insp.
Heidy C Perales1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(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 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ampak Chemicals Incorporated'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