Seattle Bioceramics, Inc
Form 483 issued July 1, 2024 · Kent, Washington
- Inspection
- Jun 24 – Jul 1, 2024
- Investigator
- Brian R. Hendricks
- Observations
- 7
- Pages
- 5
- FEI number
- 3020611371
In short: On July 1, 2024, FDA issued a Form 483 with 7 observations to Seattle Bioceramics, Inc in Kent, Washington (FEI 3020611371) after an inspection that ran Jun 24 – Jul 1, 2024. The investigator was Brian R. Hendricks. Most observations concern records & documents and cAPA.
At a glance
Observations span 4 systems, led by records & documents.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
A device master record…
- 03
Procedmes for device history records…
- 04
The design history file…
This inspection in context
Brian R. Hendricks
6 documents · 2024–2026
Cites 820.10 (requirements for a quality management system) more than any other section. Most of their documents are for sites in Washington.
The firmSeattle Bioceramics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seattle Bioceramics, Inc?
FDA listed 7 observations on this Form 483, mostly about records & documents, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Seattle Bioceramics, Inc?
Brian R. Hendricks is named on this Form 483, for the inspection of Jun 24 – Jul 1, 2024. Each investigator has a profile showing what they cite most.
When was Seattle Bioceramics, Inc inspected by FDA?
The inspection ran Jun 24 – Jul 1, 2024, and the Form 483 is dated July 1, 2024.
How do I get the full Form 483 for Seattle Bioceramics, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.