FDA 483 - Seaway Pharma Inc. - September 15, 2021

Seaway Pharma received an FDA Form 483 citing eleven observations primarily related to inadequate quality control, production, and laboratory procedures. Key issues include failures to thoroughly investigate microbial contamination and product complaints, lack of written procedures for process validation and equipment operation, and deficiencies in equipment maintenance, calibration, and data integrity. The firm also failed to ensure proper storage conditions and to use stability testing results to determine expiration dates.