Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-30.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 May 2025 – 30 May 2025 | Human Drugs | 483 | View 483 → |
| 29 Jan 2024 – 9 Feb 2024 | Human Drugs | 483 | View 483 → |
| 7 Feb 2019 – 15 Feb 2019 | Human Drugs | 483 | On file |
| 11 Sep 2017 – 14 Sep 2017 | Human Drugs | Clean | |
| 6 Apr 2017 – 14 Apr 2017 | Human Drugs | Clean | |
| 5 May 2014 – 13 May 2014 | Human Drugs | WL | View 483 → |
| 17 Nov 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 May 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Tamil Arasu, Lauren N Howard
30 May 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Lauren N Howard
9 Feb 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Patty P Kaewussdangkul, Pratik S Upadhyay
9 Feb 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Patty P Kaewussdangkul, Pratik S Upadhyay
9 Feb 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Patty P Kaewussdangkul, Pratik S Upadhyay
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu2 insp.
Lauren N Howard1 insp.
Patty P Kaewussdangkul1 insp.
Pratik S Upadhyay1 insp.
Sony Mathews1 insp.
Gayle S Lawson1 insp.
Kenneth H Williams1 insp.
Dipesh K Shah1 insp.
Peter E Baker1 insp.
Minh D Phan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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(a) | 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 Micro Labs Limited's 4 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