Apollo Care, LLC
Form 483 issued July 28, 2026 · Columbia, Missouri
- Inspection
- Jul 13 – Jul 28, 2026
- Investigators
- Kelly M. Bromley· Matthew Schuckmann· Tyler Peterson
- Observations
- 7
- Pages
- 9
- FEI number
- 3013927023
In short: On July 28, 2026, FDA issued a Form 483 with 7 observations to Apollo Care, LLC in Columbia, Missouri (FEI 3013927023) after an inspection that ran Jul 13 – Jul 28, 2026. The investigators were Kelly M. Bromley, Matthew Schuckmann and Tyler Peterson. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 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
There is a failure ofthe quality control unit to secure their responsibility and authority to approve…
- 02
(Repeat) Your firm failed to establish and follow appropriate written procedures that are designed to prevent…
- 03
(Repeat) There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch…
- 04
(Repeat) Your firm failed…
This inspection in context
Kelly M. Bromley
4 documents · 2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmApollo Care, LLC history
All 6 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 Apollo Care, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Apollo Care, LLC?
Kelly M. Bromley, Matthew Schuckmann and Tyler Peterson are named on this Form 483, for the inspection of Jul 13 – Jul 28, 2026. Each investigator has a profile showing what they cite most.
When was Apollo Care, LLC inspected by FDA?
The inspection ran Jul 13 – Jul 28, 2026, and the Form 483 is dated July 28, 2026.
How do I get the full Form 483 for Apollo Care, 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.