Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-04-14.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Apr 2023 – 14 Apr 2023 | Human Drugs | Clean | |
| 17 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 13 Nov 2017 – 15 Nov 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Darren S Brown, Mark C Saale, Bapu R Gaddam
21 Dec 2018
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Darren S Brown, Mark C Saale, Bapu R Gaddam
21 Dec 2018
21 CFR 211.160(b)(1)
Sampling and testing procedures described
Cited by Darren S Brown, Mark C Saale, Bapu R Gaddam
21 Dec 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Darren S Brown, Mark C Saale, Bapu R Gaddam
21 Dec 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Darren S Brown, Mark C Saale, Bapu R Gaddam
Investigators
FDA investigators tied to this site in the record.
Rachael O Oyewole1 insp.
Darren S Brown1 insp.
Mark C Saale1 insp.
Bapu R Gaddam1 insp.
Saleem A Akhtar1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Analys Lab Private Limited's 1 Form 483
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