Avasol LLC
Form 483 issued February 12, 2025 · Santa Barbara, California
- Inspection
- Feb 3 – Feb 12, 2025
- Investigator
- Sara H. Gabel
- Observations
- 4
- Pages
- 4
- FEI number
- 3014630458
In short: On February 12, 2025, FDA issued a Form 483 with 4 observations to Avasol LLC in Santa Barbara, California (FEI 3014630458) after an inspection that ran Feb 3 – Feb 12, 2025. The investigator was Sara H. Gabel. Most observations concern quality system and laboratory controls.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of major equipment cleaning, maintenance and use are not included…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Written records are not always made of…
This inspection in context
Sara H. Gabel
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAvasol LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avasol LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Avasol LLC?
Sara H. Gabel is named on this Form 483, for the inspection of Feb 3 – Feb 12, 2025. Each investigator has a profile showing what they cite most.
When was Avasol LLC inspected by FDA?
The inspection ran Feb 3 – Feb 12, 2025, and the Form 483 is dated February 12, 2025.
How do I get the full Form 483 for Avasol 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.