FDA 483 - Sparhawk Laboratories Inc - March 23, 2021

Sparhawk Laboratories Inc, an animal drug manufacturer in Lenexa, KS, received a Form 483 with three observations during an FDA inspection. The firm was cited for inadequate computer controls and data integrity issues, including a repeat observation regarding HPLC data and unprotected spreadsheet formulas. Additionally, the inspection revealed deficiencies in aseptic process validation and a lack of established procedures for preventing microbiological contamination, specifically concerning employee qualification for aseptic operations.