Vital Care Compounder LLC
Form 483 issued October 13, 2022 · Hattiesburg, Mississippi
- Inspection
- Oct 3 – Oct 13, 2022
- Investigators
- Jared P. Stevens· Jessica P. McAlister· Martrice A. Packer
- Observations
- 10
- Pages
- 7
- FEI number
- 3010241801
In short: On October 13, 2022, FDA issued a Form 483 with 10 observations to Vital Care Compounder LLC in Hattiesburg, Mississippi (FEI 3010241801) after an inspection that ran Oct 3 – Oct 13, 2022. The investigators were Jared P. Stevens, Jessica P. McAlister and Martrice A. Packer. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 2 systems, led by production.
Most cited: FDCA 501(a)(2)(A) (8×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02FDCA 501(a)(2)(A)
Observation 2: scanned text, readable in the full document.
- 03FDCA 501(a)(2)(A)
The final containers/closures used for drug product intended to be sterile were…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmVital Care Compounder LLC history
All 5 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 Compounder LLC?
FDA listed 10 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Vital Care Compounder LLC?
Jared P. Stevens, Jessica P. McAlister and Martrice A. Packer are named on this Form 483, for the inspection of Oct 3 – Oct 13, 2022. Each investigator has a profile showing what they cite most.
When was Vital Care Compounder LLC inspected by FDA?
The inspection ran Oct 3 – Oct 13, 2022, and the Form 483 is dated October 13, 2022.
How do I get the full Form 483 for Vital Care Compounder 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.