Biomedix WAI
Form 483 issued October 31, 2019 · Bloomington, Indiana
- Inspection
- Oct 21 – Oct 31, 2019
- Investigator
- Joseph R. Strelnik
- Observations
- 11
- Pages
- 14
- FEI number
- 1000115518
In short: On October 31, 2019, FDA issued a Form 483 with 11 observations to Biomedix WAI in Bloomington, Indiana (FEI 1000115518) after an inspection that ran Oct 21 – Oct 31, 2019. The investigator was Joseph R. Strelnik. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
7 of 11 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results caimot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for monitoring and control of process parameters for a validated process have not been adequately…
- 03
Procedures for the acceptance of in-process product have…
- 04
Procedures to control environmental conditions have not been adequately established. This is a repeat of Observation…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmBiomedix WAI history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomedix WAI?
FDA listed 11 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Biomedix WAI?
Joseph R. Strelnik is named on this Form 483, for the inspection of Oct 21 – Oct 31, 2019. Each investigator has a profile showing what they cite most.
When was Biomedix WAI inspected by FDA?
The inspection ran Oct 21 – Oct 31, 2019, and the Form 483 is dated October 31, 2019.
How do I get the full Form 483 for Biomedix WAI?
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.