Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-03.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2026 – 3 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 8 Jul 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Shawn Choi
3 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Shawn Choi
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 |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Pregis Protective Films & Coatings LLC's 1 Form 483
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