FDA Inspection
Seattle Bioceramics, Inc.Seattle Bioceramics, Inc. – FDA Inspection, Jul 1, 2024
Record Details
This FDA Inspection record concerns Seattle Bioceramics, Inc., with an inspection on July 1, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · fbcc4496-1908-4a6b-be2b-61938084a59c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242650
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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.