Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
8
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 1 May 2026 | Human Drugs | 483 | On file |
| 26 Aug 2019 – 30 Aug 2019 | Human Drugs | 483 | On file |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | Clean | |
| 19 Mar 2018 – 27 Mar 2018 | Human Drugs | 483 | View 483 → |
| 20 Sep 2016 – 29 Sep 2016 | Human Drugs | 483 | View 483 → |
| 21 Oct 2013 – 25 Oct 2013 | Human Drugs | 483 | View 483 → |
| 9 Dec 2011 | Not recorded | 483 | On file |
| 10 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2018
21 CFR 211.105(a)
Identification of containers, lines, equipment
Cited by Dipesh K Shah, June P Page, Kellia N Hicks
27 Mar 2018
21 CFR 211.110(a)(1)
Tablet or capsule weight variation
Cited by Dipesh K Shah, June P Page, Kellia N Hicks
27 Mar 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Dipesh K Shah, June P Page, Kellia N Hicks
27 Mar 2018
21 CFR 211.176
Failing to test for penicillin cross-contamination
Cited by Dipesh K Shah, June P Page, Kellia N Hicks
27 Mar 2018
21 CFR 211.194(a)
Complete test data included in records
Cited by Dipesh K Shah, June P Page, Kellia N Hicks
Investigators
FDA investigators tied to this site in the record.
Dipesh K Shah2 insp.
Unnee Ranjan1 insp.
Pratik S Upadhyay1 insp.
Jeffrey P Raimondi1 insp.
Scott N Lim1 insp.
June P Page1 insp.
Kellia N Hicks1 insp.
Tiara N Brown-Crosen1 insp.
Cheryl A Clausen1 insp.
Jose A Cruz Gonzalez1 insp.
Matthew B Casale1 insp.
Walden H Lee1 insp.
Rochelle B Young1 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 | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alkem Laboratories Limited's 6 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