FDA EIR - SriSai Biopharmaceutical Solutions LLC - September 24, 2010

The FDA conducted a routine Good Manufacturing Practice (GMP) inspection of SriSai Biopharmaceutical Solutions LLC, a drug warehouse and distributor located in Frederick, MD, from September 22 to September 24, 2010. This inspection followed the regulatory framework outlined in 21 CFR Parts 210 and 211, guided by CPGM 7356.002 for drug manufacturing inspections.

During the inspection, several systems were evaluated, including Quality, Facilities and Equipment, and Materials. Key processes such as receipt and storage were reviewed, along with documentation like standard operating procedures (SOPs), deviation reports, and Corrective and Preventative Actions (CAPAs).

The inspection resulted in an FDA 483 "Notice of Objectionable Observations" issued to Dr. Sri R. Konduru, the company's President. The main violations included the failure to thoroughly investigate deviations, inadequate validation of the temperature monitoring system and computer inventory software, improper maintenance of warehouse humidifiers, and failure to maintain walk-in coolers according to procedures. Additionally, verbal discussions highlighted the absence of a complaint log for 2006 and 2010, a recall log, and the lack of annual reviews prior to 2009.

No samples were collected during the inspection, and there were no refusals. The company is required to address the cited deficiencies to comply with FDA regulations and ensure the integrity of their operations.