FDA 483 - Unipharma, Llc. - May 07, 2019

An FDA inspection of Unipharma, Llc. conducted from April 22 to May 7, 2019, identified significant deficiencies across multiple systems, indicating a failure to adhere to Good Manufacturing Practices (GMP). Key violations included the repeated detection of *Burkholderia cepacia*, an objectionable microorganism, in the USP Purified Water system, which supplies ingredients for infant and pediatric over-the-counter (OTC) drug products like Acetaminophen. Investigations into this contamination were found to be inadequate, lacking thorough root cause analysis and effective corrective actions. The water system itself was also poorly maintained with observed leaks and discolored hoses.

Further critical issues involved the Quality Control unit failing to exercise adequate oversight, evidenced by the release of eight OTC drug batches to the market without proper Quality Assurance approval. Process validations for several marketed drug products, including infant/pediatric Acetaminophen, were either not performed prior to commercial distribution or were deficient, lacking defined acceptance criteria. The firm also lacked sufficient stability data to support the assigned two-year expiration dates for its marketed OTC drug products, with process validation batches often excluded from stability programs. Equipment calibration for weighing devices was found to be inadequate, potentially impacting product quality. Lastly, material storage and distribution controls were insufficient, including improper storage of active pharmaceutical ingredients and a lack of environmental monitoring in the GMP warehouse during non-operational hours.

Unipharma, Llc. is required to address these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards.