Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-10.
At a glance
Inspections
14
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2026 – 10 Mar 2026 | Human Drugs | 483 | View 483 → |
| 12 Oct 2022 – 21 Oct 2022 | Human Drugs | 483 | On file |
| 7 Sep 2021 – 8 Sep 2021 | Foods & Cosmetics | Clean | |
| 10 Jan 2018 – 25 Jan 2018 | Human Drugs | 483 | View 483 → |
| 28 Aug 2017 – 7 Sep 2017 | Human Drugs | Clean | |
| 8 Aug 2016 – 17 Aug 2016 | Human Drugs | 483 | View 483 → |
| 27 Jan 2014 – 13 Feb 2014 | Human Drugs | 483 | View 483 → |
| 25 Mar 2011 | Not recorded | 483 | View 483 → |
| 5 Apr 2010 | Not recorded | 483 | View 483 → |
| 26 Feb 2009 | Not recorded | 483 | View 483 → |
| 5 Oct 2007 | Not recorded | WL | |
| 7 Dec 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jonathan G Matrisciano, Ifechimere I Okafor
10 Mar 2026
21 CFR 211.122(a)
Sampling/testing of labeling/packaging materials
Cited by Jonathan G Matrisciano, Ifechimere I Okafor
10 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jonathan G Matrisciano, Ifechimere I Okafor
10 Mar 2026
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Jonathan G Matrisciano, Ifechimere I Okafor
10 Mar 2026
21 CFR 211.84(b)
Representative Samples
Cited by Jonathan G Matrisciano, Ifechimere I Okafor
Investigators
FDA investigators tied to this site in the record.
Jonathan G Matrisciano3 insp.
Robert J Martin3 insp.
Megan A Haggerty2 insp.
Ifechimere I Okafor1 insp.
Daniel L Zheng1 insp.
Gerard D Difiore1 insp.
Laura L Staples1 insp.
Maya M Davis1 insp.
Margaret E Walsh1 insp.
Rory Geyer1 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 | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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 |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lyne Laboratories, Inc.'s 8 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