Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-27.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2019 – 27 Jun 2019 | Animal Drugs & Feeds | 483 | View 483 → |
| 18 May 2016 | Animal Drugs & Feeds | Clean | |
| 19 Apr 2016 – 20 Apr 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 2 Dec 2013 – 31 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jun 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Lauren N Howard, Michael P Sheehan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(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 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hyalynx Inc's 3 Form 483s
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