Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-30.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2019 – 30 Aug 2019 | Human Drugs | WL | View 483 → |
| 28 May 2018 – 1 Jun 2018 | Human Drugs | 483 | On file |
| 17 Jul 2017 – 21 Jul 2017 | Human Drugs | Clean | |
| 15 Feb 2016 – 17 Feb 2016 | Human Drugs | Clean | |
| 9 Jun 2014 – 13 Jun 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Arsen Karapetyan, Pratik S Upadhyay
30 Aug 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Arsen Karapetyan, Pratik S Upadhyay
30 Aug 2019
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Arsen Karapetyan, Pratik S Upadhyay
Investigators
FDA investigators tied to this site in the record.
Arsen Karapetyan1 insp.
Pratik S Upadhyay1 insp.
Jose A Lopez Rubet1 insp.
Anthony J Ladner1 insp.
Felix Maldonado1 insp.
Joseph R Lambert1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Windlas Healthcare Private Limited's 3 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