2 CGMP Issues in Scientific Protein Inspection

A 4/21-5/2 FDA inspection at the Scientific Protein Laboratories drug manufacturing facility in Waunakee, WI, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 10/10 Warning Letter says the specific deviations were:

• failure to ensure that equipment surfaces in contact with raw materials, intermediates, and API do not alter the quality of the intermediates and API beyond the official or other established specifications; and
• failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications.

The letter says the firm’s responses to the inspection observations were inadequate. Scientific Protein was told to correct the deviations promptly and to respond with a list of specific steps it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the corrections.