Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-21.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Dec 2023 – 21 Dec 2023 | Human Drugs | 483 | On file |
| 4 Nov 2019 – 15 Nov 2019 | Human Drugs | 483 | On file |
| 4 Mar 2019 – 8 Mar 2019 | Human Drugs | 483 | On file |
| 20 Feb 2018 – 28 Feb 2018 | Human Drugs | 483 | On file |
| 17 Jul 2017 – 21 Jul 2017 | Human Drugs | Clean | |
| 25 Jan 2017 – 3 Feb 2017 | Human Drugs | 483 | On file |
| 1 Feb 2016 – 5 Feb 2016 | Human Drugs | 483 | On file |
| 16 Feb 2015 – 20 Feb 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2023
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Saleem A Akhtar, Cynthia Jim
21 Dec 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saleem A Akhtar, Cynthia Jim
21 Dec 2023
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Saleem A Akhtar, Cynthia Jim
21 Dec 2023
21 CFR 211.188(b)(12)
Investigations made into any unexplained discrepancy
Cited by Saleem A Akhtar, Cynthia Jim
21 Dec 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saleem A Akhtar, Cynthia Jim
Investigators
FDA investigators tied to this site in the record.
Saleem A Akhtar1 insp.
Cynthia Jim1 insp.
Jose A Cruz Gonzalez1 insp.
Guerlain Ulysse1 insp.
June P Page1 insp.
Junho Pak1 insp.
Anastasia M Shields1 insp.
Linda F Murphy1 insp.
Kumar G Janoria1 insp.
Vilmary Negron Rodriguez1 insp.
Felix Maldonado1 insp.
Luis A Dasta1 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 | 7x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Msn Laboratories Private Limited's 7 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