Vital Care of Dickson, LLC
Form 483 issued March 4, 2020 · Dickson, Tennessee
- Inspection
- Mar 4, 2020
- Investigator
- Marvin D. Jones
- Observations
- 5
- Pages
- 2
- FEI number
- 3015826069
In short: On March 4, 2020, FDA issued a Form 483 with 5 observations to Vital Care of Dickson, LLC in Dickson, Tennessee (FEI 3015826069) after an inspection that ran Mar 4, 2020. The investigator was Marvin D. Jones. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Compounding with AP!s that have not been verified to assure that they do not contribute endotoxin…
- 02
Failul'e to conduct media fill studies that closely simulate aseptic processing operations under the worst-case…
- 03
Pressure differentiaJs are not monitored in areas…
- 04
Procedures designed to prevent insanitary conditions are…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmVital Care of Dickson, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vital Care of Dickson, LLC?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Vital Care of Dickson, LLC?
Marvin D. Jones is named on this Form 483, for the inspection of Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was Vital Care of Dickson, LLC inspected by FDA?
The inspection ran Mar 4, 2020, and the Form 483 is dated March 4, 2020.
How do I get the full Form 483 for Vital Care of Dickson, 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.