FDA 483 - innovative intrathecal solutions, inc. - December 18, 2017

This FDA Form 483 documents observations from an inspection, citing deficiencies in the facility's sterile drug product manufacturing. The firm produces approximately 100 sterile drug product units daily, including Omnipaque Injection, with 30 lots produced in the last three months.

Key violations include inadequate validation of sterilization processes, specifically concerning media fill studies from January 7, 2017, and June 30, 2017. Deficiencies in these studies include: lack of growth promotion testing for media lots, absence of documented control samples, no records of media quantities used, no records of materials used, no evaluation of media fill results, and no environmental or personnel monitoring during the June 30, 2017, study. Additionally, the incubator for media samples was not qualified.

Procedures for preventing microbiological contamination are not adequately established or followed. The firm's post-lot sterility assessment is subjective, lacking quantitative measurement and specifications. On December 5, 2017, a non-sterile wipe was used inside an ISO 5 Laminar Flow Hood (LFH) to clean surfaces and container closures during Methylcobalamin Injection lot 12052017@16 preparation.

Personnel gowning materials (hair bonnet, mask, lab coat, shoe cover) used for sterile drug product preparation are not sterile grade. Environmental monitoring is not performed during sterile drug product preparation, and personnel