Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-22.
At a glance
Inspections
14
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2026 – 22 Apr 2026 | Human Drugs | 483 | View 483 → |
| 1 Nov 2022 – 29 Nov 2022 | Human Drugs | 483 | View 483 → |
| 13 Sep 2018 – 3 Oct 2018 | Human Drugs | 483 | View 483 → |
| 30 Sep 2016 – 27 Oct 2016 | Human Drugs | 483 | View 483 → |
| 3 Sep 2014 – 10 Sep 2014 | Human Drugs | Clean | |
| 14 Dec 2011 | Not recorded | 483 | View 483 → |
| 28 Oct 2010 | Not recorded | 483 | On file |
| 3 Feb 2010 | Not recorded | 483 | View 483 → |
| 22 Jun 2009 | Not recorded | 483 | View 483 → |
| 31 Jul 2007 | Not recorded | Clean | |
| 28 Jun 2005 | Not recorded | Clean | |
| 13 Aug 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Apr 2026
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Jolanna A Norton
29 Nov 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Santiago Gallardo Johnson
29 Nov 2022
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Santiago Gallardo Johnson
29 Nov 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
Sundy Ven2 insp.
Zachary A Bogorad2 insp.
Jolanna A Norton1 insp.
Santiago Gallardo Johnson1 insp.
Taichun Qin1 insp.
Albert C Cheng1 insp.
Marcus F Yambot1 insp.
Sundy V Sedwick1 insp.
Terrance P Nguyen1 insp.
Caryn M Mcnab1 insp.
Babajide M Osunsanmi1 insp.
Linda Thai1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hyland's Consumer Health 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