FDA 483 - PharmaGend Global Medical Services Pte. Ltd. - February 01, 2019

During an inspection of Strides Pharma Global Pte Limited in Singapore, the FDA observed deficiencies in control procedures for manufacturing processes, specifically concerning a deficient hold time study protocol. Additionally, the firm's written procedures for cleaning and maintenance were found to lack sufficient detail, particularly regarding the justification of swab sampling locations for equipment cleaning validation.