Bioimplant
FDA inspection history in Kiev, Ukraine, 2004
- 1
- Form 483
Every document, by year
- Form 483
2004: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One Form 483, at Kiev, Ukraine.
Cited most
Across all Bioimplant observations on file
- 21 CFR 1271.150Current good tissue practice requirements1
- 21 CFR 1271.180Procedures1
- 21 CFR 1271.190Facilities1
- 21 CFR 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?1
The complete Bioimplant file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kiev, Ukraine
One Form 483 · 2004 · 7 observations
Latest: Form 483, Jun 12, 2004 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2004-06-12 | 483 Form 483 | Kiev, Ukraine | 7 | $99 |
Investigators on these documents
FEI number 3007014431 · most recent document Jun 12, 2004
About Bioimplant
How many FDA Form 483s has Bioimplant received?
FDA Intel has 1 Form 483 on file for Bioimplant; the most recent is dated Jun 12, 2004.
When was Bioimplant last inspected by FDA?
The most recent FDA inspection document on file for Bioimplant is a Form 483 dated Jun 12, 2004, for the site in Kiev, Ukraine.
What did FDA cite at Bioimplant?
The regulations cited most in the observations on file for Bioimplant are 21 CFR 1271.150 (Current good tissue practice requirements), 1 time; 21 CFR 1271.180 (Procedures), 1 time; 21 CFR 1271.190 (Facilities), 1 time.