Inspection Record

Avella of Deer Valley, Inc. dba Avella — FDA 483 Findings

US FDAInspected 2015-07-29Published 2026-03-23 3 findingsAseptic processing and sterility assuranceLabeling and packaging

Inspectors Roger F Zabinski · Sangeeta M. KhuranaThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

3Labeling and packaging

The labels and containers for some of the drug products you produce do not contain information required by section 503B(a)(10)(A) and 503B(a)(1O)(B).

About this record

Extracted automatically from the document US FDA published on 2026-03-23. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Avella of Deer Valley, Inc. dba Avella company profile — full history US FDA documents, 2026 Go to Findings search