Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Brian R Hendricks
8 May 2026
ISO 13485:2016 Clause 7.3.6
Design and development verification not performed
Cited by Brian R Hendricks
8 May 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not performed as planned
Cited by Brian R Hendricks
8 May 2026
ISO 13485:2016 Clause 7.4.1
Results of supplier monitoring not used as input into the supplier re-evaluation
Cited by Brian R Hendricks
Inspected site
POPhilips Oral Healthcare, LLCBothell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere