BioTE Medical
FDA inspection history in Irving, Texas, 2018
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One close-out letter and one Form 483, at Irving, Texas.
Cited most
Across all BioTE Medical observations on file
- 21 CFR 211.198Complaint files2
- 21 CFR 211.150Distribution procedures1
- 21 CFR 211.180General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete BioTE Medical 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
Irving, Texas
One Form 483 · 2018 · 5 observations
Latest: Form 483, Apr 23, 2018 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-05-03 | Close-out Close-out letter | — | — | $99 |
| 2018-04-23 | 483 Form 483 | Irving, Texas | 5 | $99 |
Investigators on these documents
FEI number 3012619291 · most recent document May 3, 2018
About BioTE Medical
How many FDA Form 483s has BioTE Medical received?
FDA Intel has 1 Form 483 on file for BioTE Medical; the most recent is dated Apr 23, 2018.
When was BioTE Medical last inspected by FDA?
The most recent FDA inspection document on file for BioTE Medical is a Form 483 dated Apr 23, 2018, for the site in Irving, Texas.
What did FDA cite at BioTE Medical?
The regulations cited most in the observations on file for BioTE Medical are 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.150 (Distribution procedures), 1 time; 21 CFR 211.180 (General requirements), 1 time.