Avasol LLC
Form 483 issued November 9, 2023 · Santa Barbara, California
- Inspection
- Nov 6 – Nov 9, 2023
- Observations
- 7
- Pages
- 5
- FEI number
- 3014630458
In short: On November 9, 2023, FDA issued a Form 483 with 7 observations to Avasol LLC in Santa Barbara, California (FEI 3014630458) after an inspection that ran Nov 6 – Nov 9, 2023. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Your master production and control records for each drug product were not prepared, dated, and signed…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Questions about this 483
What did FDA find at Avasol LLC?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was Avasol LLC inspected by FDA?
The inspection ran Nov 6 – Nov 9, 2023, and the Form 483 is dated November 9, 2023.
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.