Apollo Care, LLC
Form 483 issued April 5, 2023 · Columbia, Missouri
- Inspection
- Mar 7 – Apr 5, 2023
- Investigators
- Charles A. Haffner· Conner J. Mason· Wayne D. McCrary
- Observations
- 6
- Pages
- 7
- FEI number
- 3013927023
In short: On April 5, 2023, FDA issued a Form 483 with 6 observations to Apollo Care, LLC in Columbia, Missouri (FEI 3013927023) after an inspection that ran Mar 7 – Apr 5, 2023. The investigators were Charles A. Haffner, Conner J. Mason and Wayne D. McCrary. Most observations concern production and packaging & labeling; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and packaging & labeling account for 4 of 6 observations.
Most cited: 21 CFR 211.113 (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 to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Drug products are not stored under appropriate conditions of light so that their identity, strength, quality…
This inspection in context
Charles A. Haffner
1 document · 2023
Cites 211.113 (control of microbiological contamination) 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 211.113
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 production, packaging & labeling and quality system. 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 Apollo Care, LLC?
Charles A. Haffner, Conner J. Mason and Wayne D. McCrary are named on this Form 483, for the inspection of Mar 7 – Apr 5, 2023. Each investigator has a profile showing what they cite most.
When was Apollo Care, LLC inspected by FDA?
The inspection ran Mar 7 – Apr 5, 2023, and the Form 483 is dated April 5, 2023.
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.