Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-11.
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 |
|---|---|---|---|
| 8 Sep 2019 – 11 Sep 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Rachael A Moliver, Michael E Maselli
11 Sep 2019
21 CFR 211.166(a)
Lack of written stability program
Cited by Rachael A Moliver, Michael E Maselli
11 Sep 2019
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Rachael A Moliver, Michael E Maselli
11 Sep 2019
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Rachael A Moliver, Michael E Maselli
Investigators
FDA investigators tied to this site in the record.
Rachael A Moliver1 insp.
Michael E Maselli1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Peer Pharm Ltd.'s 1 Form 483
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