Purisys LLC
Form 483 issued March 13, 2024 · Athens, Georgia
- Investigators
- J'maica J. Hunter· Veronica Fuentes
- Observations
- 2
- Pages
- 3
- FEI number
- 3012286613
In short: On March 13, 2024, FDA issued a Form 483 with 2 observations to Purisys LLC in Athens, Georgia (FEI 3012286613). The investigators were J'maica J. Hunter and Veronica Fuentes. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.56(a) (1×) · 211.80(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Written procedures are lacking which describe in sufficient detail the handling…
This inspection in context
J'maica J. Hunter
5 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Georgia.
The firmPurisys LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Purisys LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Purisys LLC?
J'maica J. Hunter and Veronica Fuentes are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Purisys LLC inspected by FDA?
This Form 483 is dated March 13, 2024.
How do I get the full Form 483 for Purisys 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.