FDA WARNING_LETTER - Oklahoma Respiratory Care, Inc. - October 28, 2011

On October 19-28, 2011, an FDA inspection of Oklahoma Respiratory Care, Inc.'s pharmaceutical manufacturing facility identified significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Lack of Final Product Testing:** The firm failed to perform identity and purity testing on incoming oxygen or finished Oxygen USP batches prior to release (21 CFR § 211.165(a)). Employees responsible for transfilling oxygen documented completion of testing on batch records despite not performing it or receiving training on the oxygen analyzer. The firm could not determine when testing was last completed. 2. **Inadequate Quality Control Unit (QCU) Review:** The QCU failed to review and approve production and control records to ensure compliance before batch release (21 CFR § 211.192). From January 1, 2011, to October 18, 2011, the QCU employee responsible for review did not verify identity and purity testing for 59 lots of Oxygen, USP. Batch records from 2003 to present lacked documentation of purity testing, and the QCU employee admitted to never reviewing records to confirm products met specifications. 3. **Unsupported Expiration Dates:** The firm used a 5-year expiration date for