FDA 483 - I.V. Specialty, Ltd - February 05, 2016

During an FDA inspection from January 25 to February 5, 2016, I.V. Specialty, Ltd., a producer of sterile drug products in Austin, TX, was cited with eight observations on Form FDA 483, several of which were repeat issues from a previous inspection. The primary violations centered on significant deficiencies in aseptic processing areas and quality control systems, indicating a failure to adhere to Good Manufacturing Practices (GMP).

Key issues included structural deficiencies in cleanrooms, such as damaged work surfaces, dirty HEPA covers, and non-compliant ceiling materials, leading to consistently high microbial counts and expired room certifications. The firm also failed to conduct adequate sterility and endotoxin testing for all sterile drug products, using unvalidated methods and improper procedures. Personnel gowning practices were inadequate, with non-sterile attire and improper aseptic techniques observed.

Further observations detailed a lack of established and followed procedures to prevent microbiological contamination, including poor glove hygiene, spraying near open sterile products, and using soiled or rusted equipment. Cleaning and disinfection protocols were insufficient, utilizing expired sanitizers and non-sterile tools, resulting in visible residues. Environmental monitoring was deficient, relying on third-party certification rather than internal, active monitoring. The company also lacked thorough investigations for discrepancies like product leaks or particles, and failed to formally address patient complaints. Finally, critical equipment, including calibration weights, incubator thermometers, and pressure gauges, were found to be uncalibrated, jeopardizing product quality.

To achieve compliance with the Federal Food, Drug, and Cosmetic Act, I.V. Specialty, Ltd. is required to implement comprehensive corrective and preventive actions to address these systemic failures in facility design, manufacturing controls, quality assurance, and equipment maintenance.