Avanti Polar Lipids
Form 483 issued July 7, 2023 · Alabaster, Alabama
- Inspection
- Jan 5 – Jul 7, 2023
- Investigator
- Martrice A. Packer
- Observations
- 1
- Pages
- 3
- FEI number
- 1036868
In short: On July 7, 2023, FDA issued a Form 483 with 1 observation to Avanti Polar Lipids in Alabaster, Alabama (FEI 1036868) after an inspection that ran Jan 5 – Jul 7, 2023. The investigator was Martrice A. Packer. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Martrice A. Packer
6 documents · 2022–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Alabama.
The firmAvanti Polar Lipids history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avanti Polar Lipids?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Avanti Polar Lipids?
Martrice A. Packer is named on this Form 483, for the inspection of Jan 5 – Jul 7, 2023. Each investigator has a profile showing what they cite most.
When was Avanti Polar Lipids inspected by FDA?
The inspection ran Jan 5 – Jul 7, 2023, and the Form 483 is dated July 7, 2023.
How do I get the full Form 483 for Avanti Polar Lipids?
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.