HomeChoice Partners, Inc.
Form 483 issued August 9, 2021 · Augusta, Georgia
- Inspection
- Aug 2 – Aug 9, 2021
- Investigators
- Song Y. Lavalais· Veronica Fuentes
- Observations
- 2
- Pages
- 2
- FEI number
- 3014461693
In short: On August 9, 2021, FDA issued a Form 483 with 2 observations to HomeChoice Partners, Inc. in Augusta, Georgia (FEI 3014461693) after an inspection that ran Aug 2 – Aug 9, 2021. The investigators were Song Y. Lavalais and Veronica Fuentes. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
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
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area [aseptic processing areas]…
- 02
The finn lacks smoke studies performed under dynamic conditions that…
This inspection in context
Song Y. Lavalais
5 documents · 2021–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
The firmHomeChoice Partners, Inc. history
All 3 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 HomeChoice Partners, Inc.?
FDA listed 2 observations on this Form 483, mostly about production. 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 HomeChoice Partners, Inc.?
Song Y. Lavalais and Veronica Fuentes are named on this Form 483, for the inspection of Aug 2 – Aug 9, 2021. Each investigator has a profile showing what they cite most.
When was HomeChoice Partners, Inc. inspected by FDA?
The inspection ran Aug 2 – Aug 9, 2021, and the Form 483 is dated August 9, 2021.
How do I get the full Form 483 for HomeChoice Partners, 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.