483
Promise Pharmacy, LLCFDA 483 - Promise Pharmacy, LLC - September 23, 2021
Discuss this record with AI
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.
Record Details
Promise Pharmacy, LLC in Palm Harbor, FL, was inspected and received a Form 483 with two observations. The inspection revealed the routine use of non-pharmaceutical grade components in the formulation of both sterile and non-sterile drug products. Additionally, personnel were observed failing to maintain aseptic technique by not changing or sanitizing gloves after touching non-ISO 5 surfaces before returning to aseptic processing.
Open in Dashboard
ID · 1fd494b0-82d0-4850-8ef7-13a0159237a2