Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-17.
At a glance
Inspections
10
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 May 2024 – 17 May 2024 | Human Drugs | 483 | View 483 → |
| 18 Oct 2021 – 29 Oct 2021 | Human Drugs | 483 | View 483 → |
| 12 Aug 2019 – 20 Aug 2019 | Human Drugs | 483 | View 483 → |
| 13 Jun 2019 – 21 Jun 2019 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 30 Oct 2018 | Human Drugs | 483 | On file |
| 27 Feb 2017 – 8 Mar 2017 | Human Drugs | 483 | On file |
| 27 Feb 2015 – 6 Mar 2015 | Human Drugs | 483 | On file |
| 31 Jan 2013 | Not recorded | Clean | |
| 20 Nov 2009 | Not recorded | Clean | |
| 21 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Oct 2021
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Rita K Kabaso, Nancy M Espinal
29 Oct 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rita K Kabaso, Nancy M Espinal
Investigators
FDA investigators tied to this site in the record.
Thomas J Arista2 insp.
Michael A Charles1 insp.
Rita K Kabaso1 insp.
Nancy M Espinal1 insp.
Bijoy Panicker1 insp.
Farhana Khan1 insp.
Monica C Burgos Garcia1 insp.
Jose E Melendez1 insp.
Junho Pak1 insp.
Justin A Boyd1 insp.
Toyin B Oladimeji1 insp.
Michael R Klapal1 insp.
Steven M Weinman1 insp.
Justine Tomasso1 insp.
Jeremy W Rotton1 insp.
Michael R Goga1 insp.
Susan M Jackson1 insp.
Alicia M Mozzachio1 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 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DR.REDDY'S LABORATORIES LIMITED's 8 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