FDA 483 - Sparhawk Laboratories Inc - February 28, 2020

Sparhawk Laboratories Inc., an animal drug manufacturer in Lenexa, KS, was cited for significant deficiencies across multiple areas during an FDA inspection. The observations highlight failures in complaint handling, data integrity for analytical testing, inadequate stability testing to support storage conditions, incomplete batch records, and a lack of robust written procedures for critical production and process controls, including those for preventing microbiological contamination in sterile products. These issues indicate a systemic lack of control over critical quality systems.