Avenue Pharmacy Inc dba Pathway PharmacyJune 22, 2021

FDA 483 - Avenue Pharmacy Inc dba Pathway Pharmacy - June 22, 2021

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Avenue Pharmacy Inc dba Pathway Pharmacy

Record Details

Avenue Pharmacy Inc dba Pathway Pharmacy in Ocala, FL, was cited for significant deficiencies during an inspection from June 14-22, 2021. Observations included non-microbial contamination in the production area, specifically a grocery bag used to cover an opening on a hazardous hood. Additionally, the firm released drug products with incorrect strength, purity, or quality due to active pharmaceutical ingredients being weighed outside calibrated scale ranges.

Company: Avenue Pharmacy Inc dba Pathway Pharmacy
Inspection Date: June 22, 2021
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Jessica L. Pressley (Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre)

Open in Dashboard

ID · 705227b4-6510-45c7-a6ad-5ec959cf0b1e