Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-21.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 May 2024 – 21 May 2024 | Human Drugs | 483 | View 483 → |
| 16 Jan 2023 – 20 Jan 2023 | Human Drugs | 483 | On file |
| 7 Mar 2022 – 16 Mar 2022 | Human Drugs | Clean | |
| 16 Dec 2019 – 20 Dec 2019 | Human Drugs | 483 | On file |
| 22 Apr 2019 – 26 Apr 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Teresa I Navas1 insp.
Lata C Mathew1 insp.
Jose M Cayuela1 insp.
Jose E Melendez1 insp.
Anitha P Govada1 insp.
Jason R Caballero1 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 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ZENARA PHARMA PRIVATE LIMITED's 4 Form 483s
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