Biomedix WAI
FDA inspection history in Bloomington, Indiana, 2019 to 2020
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One Form 483 and one close-out letter, at Bloomington, Indiana.
Cited most
Across all Biomedix WAI observations on file
- 21 CFR 820.70(c)Production and process controls2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.250(b)Statistical techniques1
The complete Biomedix WAI file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bloomington, Indiana
One close-out letter and one Form 483 · 2019 to 2020 · 11 observations
Latest: Close-out, Feb 12, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-12 | Close-out Close-out letter | Bloomington, Indiana | — | $99 |
| 2019-10-31 | 483 Form 483 | Bloomington, Indiana | 11 | $99 |
Investigators on these documents
FEI number 1000115518 · most recent document Feb 12, 2020
About Biomedix WAI
How many FDA Form 483s has Biomedix WAI received?
FDA Intel has 1 Form 483 on file for Biomedix WAI; the most recent is dated Oct 31, 2019.
When was Biomedix WAI last inspected by FDA?
The most recent FDA inspection document on file for Biomedix WAI is a Form 483 dated Oct 31, 2019, for the site in Bloomington, Indiana.
What did FDA cite at Biomedix WAI?
The regulations cited most in the observations on file for Biomedix WAI are 21 CFR 820.70(c) (Production and process controls), 2 times; 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.