NEOLPHARMA, INC.February 5, 2019

FDA 483 - NEOLPHARMA, INC. - February 05, 2019

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Record Details

Neopharma, Inc. in Caguas, PR, was inspected from January 24 to February 5, 2019, revealing a significant issue with procedures to prevent objectionable microorganisms in non-sterile drug products. The firm has experienced recurring microbiological deviations, even after implementing corrective and preventive actions stemming from a previous inspection. This indicates a persistent problem with microbial control within their manufacturing area.

Company: NEOLPHARMA, INC.
Inspection Date: February 5, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East IV
Person: Ariel Cruz Figueroa (Retired)

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ID · 53ad6b49-3c5d-4699-9378-880fdb8b764e