Inspection Record

Avella of Deer Valley dba Avella Specialty Pharmacy — FDA 483 Findings

US FDAInspected 2018-04-19Published 2026-03-23 3 findingsOther quality systemQuality unit oversightAseptic processing and sterility assurance

Inspectors Sangeeta M Khurana · Marijo B KambereThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

DEPARTl\lJENT OF HEALTH AND HUMAN SER\'IC[S roon ;\ND DRUG ADMINISTRATION DISTRICT AODR~SS AND PHONE NUM6ER 19701 Fairchild Irvine , CA 92612- 24 45 (949 ) 608- 2900 Fax : (949) 608 - 4417 NAME ANO TIRE OF lt401VIOUAl TO WKOM REPORT ISSUED John D.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

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.

Other records for this company

2018-04-25 · US FDA · 3 findings
Avella of Deer Valley dba Avella Specialty Pharmacy company profile — full history US FDA documents, 2026 Go to Findings search