Havix Group Inc d/b/a Aavis Pharmaceuticals
Form 483 issued April 19, 2022 · Hoschton, Georgia
- Inspection
- Apr 11 – Apr 19, 2022
- Investigators
- Gretchen M. Laws· Susan O. Oladeji
- Observations
- 2
- Pages
- 2
- FEI number
- 3012841169
In short: On April 19, 2022, FDA issued a Form 483 with 2 observations to Havix Group Inc d/b/a Aavis Pharmaceuticals in Hoschton, Georgia (FEI 3012841169) after an inspection that ran Apr 11 – Apr 19, 2022. The investigators were Gretchen M. Laws and Susan O. Oladeji. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Gretchen M. Laws
2 documents · 2022–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
The firmHavix Group Inc d/b/a Aavis Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Havix Group Inc d/b/a Aavis Pharmaceuticals?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Havix Group Inc d/b/a Aavis Pharmaceuticals?
Gretchen M. Laws and Susan O. Oladeji are named on this Form 483, for the inspection of Apr 11 – Apr 19, 2022. Each investigator has a profile showing what they cite most.
When was Havix Group Inc d/b/a Aavis Pharmaceuticals inspected by FDA?
The inspection ran Apr 11 – Apr 19, 2022, and the Form 483 is dated April 19, 2022.
How do I get the full Form 483 for Havix Group Inc d/b/a Aavis Pharmaceuticals?
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