Vital Care Compounder LLC
Form 483 issued May 16, 2019 · Hattiesburg, Mississippi
- Inspection
- May 6 – May 16, 2019
- Investigator
- Claire M. Minden
- Observations
- 10
- Pages
- 4
- FEI number
- 3010241801
In short: On May 16, 2019, FDA issued a Form 483 with 10 observations to Vital Care Compounder LLC in Hattiesburg, Mississippi (FEI 3010241801) after an inspection that ran May 6 – May 16, 2019. The investigator was Claire M. Minden. 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 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 04
Buildings used in the manufacture, processing, packing, or holding of a mug product do not have…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
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(c)(10)(iv)
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 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?
Claire M. Minden is named on this Form 483, for the inspection of May 6 – May 16, 2019. Each investigator has a profile showing what they cite most.
When was Vital Care Compounder LLC inspected by FDA?
The inspection ran May 6 – May 16, 2019, and the Form 483 is dated May 16, 2019.
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.