Apollo Care, LLC
Form 483 issued September 8, 2021 · Columbia, Missouri
- Inspection
- Aug 16 – Sep 8, 2021
- Investigators
- Brian D. Nicholson· Wayne D. McGrath
- Observations
- 5
- Pages
- 5
- FEI number
- 3013927023
In short: On September 8, 2021, FDA issued a Form 483 with 5 observations to Apollo Care, LLC in Columbia, Missouri (FEI 3013927023) after an inspection that ran Aug 16 – Sep 8, 2021. The investigators were Brian D. Nicholson and Wayne D. McGrath. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.113 (2×) · 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
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic Processing areas are deficient in that the floors, walls, ceilings, and work surfaces are not…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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?
Brian D. Nicholson and Wayne D. McGrath are named on this Form 483, for the inspection of Aug 16 – Sep 8, 2021. Each investigator has a profile showing what they cite most.
When was Apollo Care, LLC inspected by FDA?
The inspection ran Aug 16 – Sep 8, 2021, and the Form 483 is dated September 8, 2021.
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.