FDA Inspection
Philips Oral Healthcare, LLCPhilips Oral Healthcare, LLC – FDA Inspection, May 8, 2026
Record Details
This FDA Inspection record concerns Philips Oral Healthcare, LLC, with an inspection on May 8, 2026, issued by the Seattle District Office, covering medical devices & rad health.
- Company
- Philips Oral Healthcare, LLC
- Inspection Date
- May 8, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 349a1969-9659-48e7-8653-8529e54a58ab
Inspection Facts
- Inspection number
- 1312594
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
- ISO 13485:2016 Clause 7.4.1Results of supplier monitoring not used as input into the supplier re-evaluation
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Philips Oral Healthcare, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Philips Oral Healthcare, LLC
- FDA Inspection 606570 - 2009-07-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.