Vital Care Compounder LLC
Form 483 issued July 7, 2016 · Hattiesburg, Mississippi
- Inspection
- Jun 3 – Jul 7, 2016
- Investigators
- Grant D. Jones· Marvin D. Jones
- Observations
- 13
- Pages
- 8
- FEI number
- 3010241801
In short: On July 7, 2016, FDA issued a Form 483 with 13 observations to Vital Care Compounder LLC in Hattiesburg, Mississippi (FEI 3010241801) after an inspection that ran Jun 3 – Jul 7, 2016. The investigators were Grant D. Jones and Marvin D. Jones. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 8 of 12 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processtng areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Grant D. Jones
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vital Care Compounder LLC?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Compounder LLC?
Grant D. Jones and Marvin D. Jones are named on this Form 483, for the inspection of Jun 3 – Jul 7, 2016. Each investigator has a profile showing what they cite most.
When was Vital Care Compounder LLC inspected by FDA?
The inspection ran Jun 3 – Jul 7, 2016, and the Form 483 is dated July 7, 2016.
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.