Custom Healthcare Systems, Inc
Form 483 issued September 4, 2019 · Richmond, Virginia
- Inspection
- Aug 14 – Sep 4, 2019
- Investigator
- Joey C. West
- Observations
- 2
- Pages
- 4
In short: On September 4, 2019, FDA issued a Form 483 with 2 observations to Custom Healthcare Systems, Inc in Richmond, Virginia after an inspection that ran Aug 14 – Sep 4, 2019. The investigator was Joey C. West. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 806.20 (records of corrections and removals not required to be reported).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 806.20 (1×) · 820.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Joey C. West
8 documents · 2009–2019
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Virginia.
The firmCustom Healthcare Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Healthcare Systems, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 806.20 (records of corrections and removals not required to be reported). The opening words of each observation are shown on this page.
Who inspected Custom Healthcare Systems, Inc?
Joey C. West is named on this Form 483, for the inspection of Aug 14 – Sep 4, 2019. Each investigator has a profile showing what they cite most.
When was Custom Healthcare Systems, Inc inspected by FDA?
The inspection ran Aug 14 – Sep 4, 2019, and the Form 483 is dated September 4, 2019.
How do I get the full Form 483 for Custom Healthcare Systems, Inc?
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.