FDA WARNING_LETTER - Gipsco Investment Corp - June 09, 2017

From June 5-9, 2017, the FDA inspected Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy, identifying serious deficiencies in sterile drug product production and failure to meet Section 503A of the FDCA conditions.

Violations include compounding drug products with melatonin, which is not eligible for 503A exemptions as it lacks a USP/NF monograph, is not an FDA-approved drug component, and is not on the 503A bulks list. This renders these products unapproved new drugs, misbranded for lacking adequate directions for use, and subject to CGMP requirements.

The facility produced adulterated drug products under insanitary conditions, including an operator leaning into an ISO-5 area with non-sterile gown sleeves on the work surface, use of non-pharmaceutical grade (b)(4) for blanketing sterile solutions, a loose, unsealed light fixture in the clean room, and inadequate autoclave sterilization temperatures (not exceeding (b)(4)°C for (b)(4) of (b)(4) cycles when (b)(4)°C was required).

The firm's June 30, 2017, response to the FDA 483 was deemed inadequate due to insufficient supporting documentation for corrective actions like using sterile gowns, preventing operator entry into ISO-5 areas, ceasing (b)(4) use, and repairing the light fixture.