Promise Pharmacy, LLC – FDA 483, Sep 23, 2021
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.
ID · 1fd494b0-82d0-4850-8ef7-13a0159237a2
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