Apollo Care, LLC
Form 483 issued March 13, 2018 · Columbia, Missouri
- Inspection
- Feb 12 – Mar 13, 2018
- Investigator
- Michele Perry Williams
- Observations
- 12
- Pages
- 12
- FEI number
- 3023927023
In short: On March 13, 2018, FDA issued a Form 483 with 12 observations to Apollo Care, LLC in Columbia, Missouri (FEI 3023927023) after an inspection that ran Feb 12 – Mar 13, 2018. The investigator was Michele Perry Williams. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.80 (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 no Quality…
- 02
Written records of investigations into unexplained discrepancies or the failure of a batch or any of…
- 03
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Michele Perry Williams
22 documents · 2009–2023
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apollo Care, LLC?
FDA listed 12 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Apollo Care, LLC?
Michele Perry Williams is named on this Form 483, for the inspection of Feb 12 – Mar 13, 2018. Each investigator has a profile showing what they cite most.
When was Apollo Care, LLC inspected by FDA?
The inspection ran Feb 12 – Mar 13, 2018, and the Form 483 is dated March 13, 2018.
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.