Seattle Bioceramics, Inc
FDA inspection history in Kent, Washington, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Kent, Washington.
Cited most
Across all Seattle Bioceramics observations on file
- 21 CFR 8301
- 21 CFR 801.20(a)Label to bear a unique device identifier1
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.181Device master record1
- 21 CFR 820.184Device history record1
The complete Seattle Bioceramics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kent, Washington
One Form 483 · 2024 · 7 observations
Latest: Form 483, Jul 1, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-01 | 483 Form 483 | Kent, Washington | 7 | $99 |
Investigators on these documents
FEI number 3020611371 · most recent document Jul 1, 2024
About Seattle Bioceramics, Inc
How many FDA Form 483s has Seattle Bioceramics, Inc received?
FDA Intel has 1 Form 483 on file for Seattle Bioceramics, Inc; the most recent is dated Jul 1, 2024.
When was Seattle Bioceramics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Seattle Bioceramics, Inc is a Form 483 dated Jul 1, 2024, for the site in Kent, Washington.
What did FDA cite at Seattle Bioceramics, Inc?
The regulations cited most in the observations on file for Seattle Bioceramics, Inc are 21 CFR 830, 1 time; 21 CFR 801.20(a) (Label to bear a unique device identifier), 1 time; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time.