Bioimplant
Form 483 issued June 12, 2004 · Kiev, Ukraine
- Inspection
- Jun 1 – Jun 12, 2004
- Investigators
- Luis A. Carrion· M. K. Lavtcre
- Observations
- 7
- Pages
- 7
- FEI number
- 3007014431
In short: On June 12, 2004, FDA issued a Form 483 with 7 observations to Bioimplant in Kiev, Ukraine (FEI 3007014431) after an inspection that ran Jun 1 – Jun 12, 2004. The investigators were Luis A. Carrion and M. K. Lavtcre. Most observations concern hCT/P.
At a glance
4 of 6 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures appropriove to meet…
- 02
Non-ConForrte 5 not were…
- 03
Lnbrnetion on Eke. (event med iC / Com fo-nied by a Stotertent oF authenticity…
- 04
You did not ensure…
This inspection in context
Luis A. Carrion
2 documents · 2004–2009
Cites 1271.190 (facilities) more than any other section. Most of their documents are for sites in Florida.
The firmBioimplant history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioimplant?
FDA listed 7 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected Bioimplant?
Luis A. Carrion and M. K. Lavtcre are named on this Form 483, for the inspection of Jun 1 – Jun 12, 2004. Each investigator has a profile showing what they cite most.
When was Bioimplant inspected by FDA?
The inspection ran Jun 1 – Jun 12, 2004, and the Form 483 is dated June 12, 2004.
How do I get the full Form 483 for Bioimplant?
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.