Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 24 Apr 2026 | Human Drugs | 483 | View 483 → |
| 10 Mar 2025 – 14 Mar 2025 | Human Drugs | 483 | On file |
| 29 May 2023 – 2 Jun 2023 | Human Drugs | 483 | On file |
| 29 Jul 2019 – 2 Aug 2019 | Human Drugs | 483 | On file |
| 16 Jan 2017 – 20 Jan 2017 | Human Drugs | 483 | On file |
| 17 Oct 2016 – 19 Oct 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Karishma G Gopaul
24 Apr 2026
21 CFR 211.160(b)(2)
In-process sample representation/identification
Cited by Anastasia M Shields, Karishma G Gopaul
24 Apr 2026
21 CFR 211.63
Equipment Design, Size and Location
Cited by Anastasia M Shields, Karishma G Gopaul
2 Jun 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Teresa I Navas
2 Jun 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Teresa I Navas
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Karishma G Gopaul1 insp.
Guerlain Ulysse1 insp.
Miral B Patel1 insp.
Teresa I Navas1 insp.
Jeffrey P Raimondi1 insp.
Liming Zhang1 insp.
Tracey L Harris1 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 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Oxalis Labs' 5 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