FDA WARNING_LETTER - Hospira Healthcare India Pvt. Ltd. - October 10, 2012

An FDA inspection conducted from October 3-10, 2012, at Hospira Healthcare India Pvt., Ltd. in India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR Parts 210 and 211). These deviations render the firm's drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm's response was deemed to lack sufficient corrective actions.

Key violations include the failure to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes (21 CFR 211.113(b)). Specific issues noted were inadequate sanitization, improper aseptic interventions, lack of dynamic airflow studies, insufficient media fill batch records, and compromised glove sterility. Additionally, the firm failed to maintain facilities of appropriate construction to facilitate cleaning, maintenance, and proper operations (21 CFR 211.42(a)), evidenced by holes between classified areas and an inadequately designed entry/exit door affecting airflow.

FDA requires a written response within fifteen working days detailing specific corrective and preventative actions, along with supporting documentation. Failure to correct these violations may result in FDA withholding approval of new applications and refusing admission of articles manufactured at the facility into the United States. The letter also advises contacting the Drug Shortages Program if production is reduced.