Overview
- 18 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-20.
At a glance
Inspections
18
Form 483s
7
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 – 20 May 2026 | Foods & Cosmetics | Clean | |
| 23 Feb 2026 – 27 Feb 2026 | Human Drugs | 483 | On file |
| 22 Feb 2022 – 4 Mar 2022 | Human Drugs | 483 | View 483 → |
| 31 Jul 2017 – 2 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2017 – 3 Feb 2017 | Human Drugs | 483 | View 483 → |
| 16 Apr 2015 – 24 Apr 2015 | Human Drugs | 483 | View 483 → |
| 5 Dec 2013 – 14 Jan 2014 | Human Drugs | 483 | View 483 → |
| 13 Dec 2011 | Not recorded | 483 | On file |
| 7 Jan 2011 | Not recorded | Clean | |
| 18 Aug 2010 | Not recorded | Clean | |
| 26 Aug 2009 | Not recorded | 483 | On file |
| 17 Jul 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2022
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jacob G Lutz, Courtney E Hillier
4 Mar 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jacob G Lutz, Courtney E Hillier
4 Mar 2022
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Jacob G Lutz, Courtney E Hillier
24 Apr 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Sarah M Meng, Cheng H Yen
Investigators
FDA investigators tied to this site in the record.
Patsy J Domingo2 insp.
Jeffrey D Meng2 insp.
Kathleen M Adams1 insp.
Ramia Brzenjy1 insp.
Shannon L Maisano1 insp.
Jacob G Lutz1 insp.
Courtney E Hillier1 insp.
David J Gasparovich1 insp.
Bei Y He1 insp.
Emilie Kahn1 insp.
Sarah M Meng1 insp.
Cheng H Yen1 insp.
Emily J Orban1 insp.
Michele L Forster1 insp.
Brian P Putz1 insp.
Caroline H Le1 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 | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ferndale Laboratories, Inc.'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