BioTE Medical
Form 483 issued April 23, 2018 · Irving, Texas
- Inspection
- Mar 19 – Apr 23, 2018
- Investigator
- Lisa Whitt
- Observations
- 5
- Pages
- 3
- FEI number
- 3012619291
In short: On April 23, 2018, FDA issued a Form 483 with 5 observations to BioTE Medical in Irving, Texas (FEI 3012619291) after an inspection that ran Mar 19 – Apr 23, 2018. The investigator was Lisa Whitt. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures describing the handling of all written and oral complaints do not include provisions for…
- 02
Complaint records are deficient in that they do not include the…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
A system by which the distribution of each lot of drug product can be readily determined…
This inspection in context
Lisa Whitt
3 documents · 2018–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmBioTE Medical history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioTE Medical?
FDA listed 5 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected BioTE Medical?
Lisa Whitt is named on this Form 483, for the inspection of Mar 19 – Apr 23, 2018. Each investigator has a profile showing what they cite most.
When was BioTE Medical inspected by FDA?
The inspection ran Mar 19 – Apr 23, 2018, and the Form 483 is dated April 23, 2018.
How do I get the full Form 483 for BioTE Medical?
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.