Medhab, LLC
Form 483 issued February 11, 2021 · Arlington, Texas
- Inspection
- Feb 8 – Feb 11, 2021
- Investigator
- Gilbert Valdez
- Observations
- 6
- Pages
- 2
- FEI number
- 3013729860
In short: On February 11, 2021, FDA issued a Form 483 with 6 observations to Medhab, LLC in Arlington, Texas (FEI 3013729860) after an inspection that ran Feb 8 – Feb 11, 2021. The investigator was Gilbert Valdez. Most observations concern management controls and cAPA.
At a glance
Management controls and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at…
- 02
Quality audits were not performed at defined intervals and at sufficient frequency to determine whether the…
- 03
Procedures for corrective and preventive action have…
- 04
Personnel training is not…
This inspection in context
Gilbert Valdez
2 documents · 2021–2023
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Texas.
The firmMedhab, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medhab, LLC?
FDA listed 6 observations on this Form 483, mostly about management controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Medhab, LLC?
Gilbert Valdez is named on this Form 483, for the inspection of Feb 8 – Feb 11, 2021. Each investigator has a profile showing what they cite most.
When was Medhab, LLC inspected by FDA?
The inspection ran Feb 8 – Feb 11, 2021, and the Form 483 is dated February 11, 2021.
How do I get the full Form 483 for Medhab, LLC?
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.