Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-10.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 10 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jun 2024 – 18 Jun 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jan 2019 – 31 Jan 2019 | Foods & Cosmetics | 483 | View 483 → |
| 8 Feb 2016 – 10 Feb 2016 | Foods & Cosmetics | Clean | |
| 18 Sep 2013 – 3 Oct 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2026
21 CFR 801.20(a)
Label to bear a unique device identifier
Cited by Ebony D Sanon, Lorraine N Williams
10 Feb 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Ebony D Sanon, Lorraine N Williams
10 Feb 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Ebony D Sanon, Lorraine N Williams
10 Feb 2026
ISO 13485:2016 Clause 4.2.3
Medical device file not established and maintained
Cited by Ebony D Sanon, Lorraine N Williams
10 Feb 2026
ISO 13485:2016 Clause 5.6.3
Management review output records lack input reviewed, decisions, and actions
Cited by Ebony D Sanon, Lorraine N Williams
Investigators
FDA investigators tied to this site in the record.
Ebony D Sanon2 insp.
Lorraine N Williams1 insp.
Marc Balzarini1 insp.
Sharon Giamberini1 insp.
Tamara J Henderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.11 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind M.d. Science Lab, L.l.c.'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