Axiobionics, LLC
FDA inspection history in Ann Arbor, Michigan, 2012 to 2024
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2012: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter, at Ann Arbor, Michigan.
- 2024One Form 483, at Ann Arbor, Michigan.
Cited most
Across all Axiobionics observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
The complete Axiobionics 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
Ann Arbor, Michigan
One Form 483 and one warning letter · 2012 to 2024 · 3 observations
Latest: Form 483, Nov 22, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Ann Arbor, Michigan | 3 | $99 |
| 2012-12-06 | Warning letter Warning letter | Ann Arbor, Michigan | — | $99 |
Investigators on these documents
FEI number 3008525454 · most recent document Nov 22, 2024
About Axiobionics, LLC
How many FDA Form 483s has Axiobionics, LLC received?
FDA Intel has 1 Form 483 on file for Axiobionics, LLC; the most recent is dated Nov 22, 2024.
When was Axiobionics, LLC last inspected by FDA?
The most recent FDA inspection document on file for Axiobionics, LLC is a Form 483 dated Nov 22, 2024, for the site in Ann Arbor, Michigan.
What did FDA cite at Axiobionics, LLC?
The regulations cited most in the observations on file for Axiobionics, LLC are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.
Has Axiobionics, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Axiobionics, LLC; the most recent is dated Dec 6, 2012.