Apollo Care, LLC
Form 483 issued March 27, 2025 · Columbia, Missouri
- Inspection
- Mar 10 – Mar 27, 2025
- Investigator
- Jolanna A. Norton
- Observations
- 6
- Pages
- 9
- FEI number
- 3013927023
In short: On March 27, 2025, FDA issued a Form 483 with 6 observations to Apollo Care, LLC in Columbia, Missouri (FEI 3013927023) after an inspection that ran Mar 10 – Mar 27, 2025. The investigator was Jolanna A. Norton. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apollo Care, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Jolanna A. Norton is named on this Form 483, for the inspection of Mar 10 – Mar 27, 2025. Each investigator has a profile showing what they cite most.
When was Apollo Care, LLC inspected by FDA?
The inspection ran Mar 10 – Mar 27, 2025, and the Form 483 is dated March 27, 2025.
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.