FDA WARNING_LETTER - High Chemical Company, Div of National Generic Distributors - February 08, 2019

The FDA issued a Warning Letter to High Chemical Company, a Division of National Generic Distributors, following an inspection from December 17, 2018, to February 8, 2019. The facility, located at 3901-A Nebraska Street, Levittown, Pennsylvania, was found to have significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Specifically, the company failed to perform appropriate quality control testing for Sarapin, a non-sterile botanical-derived API intended for sterile injectable finished drug products. This included a lack of testing for strength by dry weight, residual pesticide, and heavy metals on each batch prior to release. The firm also lacked data to support the two-year expiration date for Sarapin API.

Furthermore, Sarracenia Purpurea (Sarapin) Distillate was identified as a misbranded drug. Its labeling failed to bear adequate directions for use, specifically lacking the required statement "Caution: For manufacturing, processing, or repackaging," as per 21 CFR 201.122, despite being sold to compounding pharmacies for further processing.

The FDA acknowledged the firm's commitment to cease drug production by May 31, 2019. The letter requires a response within 15 working days detailing corrective actions, a comprehensive assessment and CAPA plan for the stability program, and clarification on