Reach Medical Inc
Form 483 issued December 30, 2022 · Collierville, Tennessee
- Inspection
- Dec 27 – Dec 30, 2022
- Investigator
- Javelle P. Spann
- Observations
- 7
- Pages
- 5
- FEI number
- 3015200846
In short: On December 30, 2022, FDA issued a Form 483 with 7 observations to Reach Medical Inc in Collierville, Tennessee (FEI 3015200846) after an inspection that ran Dec 27 – Dec 30, 2022. The investigator was Javelle P. Spann. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
Observations span 4 systems, led by capa.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Individuals who conduct quality audits have direct responsibility for…
- 03
Procedures for quality audits have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Javelle P. Spann
2 documents · 2022–2025
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Tennessee.
The firmReach Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reach Medical Inc?
FDA listed 7 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected Reach Medical Inc?
Javelle P. Spann is named on this Form 483, for the inspection of Dec 27 – Dec 30, 2022. Each investigator has a profile showing what they cite most.
When was Reach Medical Inc inspected by FDA?
The inspection ran Dec 27 – Dec 30, 2022, and the Form 483 is dated December 30, 2022.
How do I get the full Form 483 for Reach Medical Inc?
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.