Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-26.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2024 – 26 Apr 2024 | Human Drugs | 483 | On file |
| 17 Sep 2018 – 25 Sep 2018 | Human Drugs | 483 | On file |
| 21 Jan 2016 – 29 Jan 2016 | Human Drugs | 483 | View 483 → |
| 23 Jun 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Jun 2009
21 CFR 211.100(a)
Approval and review of procedures
Cited by Parul M Patel, Charisse K Green
23 Jun 2009
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Parul M Patel, Charisse K Green
23 Jun 2009
21 CFR 211.192
Written record of investigation incomplete
Cited by Parul M Patel, Charisse K Green
Investigators
FDA investigators tied to this site in the record.
Taichun Qin1 insp.
Kejun Cheng1 insp.
Vilmary Negron Rodriguez1 insp.
Sarah M Meng1 insp.
Parul M Patel1 insp.
Charisse K Green1 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 | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Berlimed SA's 4 Form 483s
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