Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-24.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2025 – 24 Jan 2025 | Human Drugs | WL | On file |
| 29 Nov 2023 – 1 Dec 2023 | Human Drugs | Clean | |
| 22 Feb 2016 – 24 Feb 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jan 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Pratik S Upadhyay, Timothy H Vo
24 Jan 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Pratik S Upadhyay, Timothy H Vo
24 Jan 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Pratik S Upadhyay, Timothy H Vo
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED's 2 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