Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-20.
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 |
|---|---|---|---|
| 11 Aug 2025 – 20 Aug 2025 | Animal Drugs & Feeds | 483 | On file |
| 21 Aug 2023 – 29 Aug 2023 | Animal Drugs & Feeds | 483 | On file |
| 9 Jan 2023 – 18 Jan 2023 | Animal Drugs & Feeds | 483 | On file |
| 4 Jan 2022 – 15 Jan 2022 | Animal Drugs & Feeds | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Aug 2023
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Nicole E Knowlton, Lillian S Wu
29 Aug 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicole E Knowlton, Lillian S Wu
Investigators
FDA investigators tied to this site in the record.
Rajiv R Srivastava1 insp.
Laura S Huffman1 insp.
Adam M Derr1 insp.
Nicole E Knowlton1 insp.
Lillian S Wu1 insp.
Michael A Charles1 insp.
Kellia N Hicks1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | 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 Cronus Pharma Specialities India Pvt Ltd'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