FDA WARNING_LETTER - RC Compounding Services, LLC - February 07, 2013

On July 14, 2014, the FDA issued a Warning Letter to RC Compounding Services, LLC, following an inspection from February 5-7, 2013. The inspection revealed serious deficiencies in the production of sterile drug products, specifically regarding insanitary conditions and poor aseptic practices.

Key violations included performing aseptic processing in a room with a wall-mounted air conditioning unit, lacking an adequate system for cleaning and disinfecting the room and equipment to achieve aseptic conditions, and using non-sterile gowns for manufacturing personnel, failing to protect drug products from contamination. Investigators observed repackaging of Avastin for ophthalmic use under conditions inappropriate for ensuring sterility.

These conditions caused drug products to be adulterated under Section 501(a)(2)(A) of the FDCA. The introduction of these adulterated products into interstate commerce is a prohibited act under Section 301(a) and 301(k) of the FDCA.

The firm failed to respond to the FDA Form 483 issued on February 7, 2013, though they stated a wish to rescind their FDA registration as a repackager on February 6, 2013, and registered as a 503B outsourcing facility on February 12, 2014.

The FDA strongly recommended a comprehensive assessment of manufacturing operations, including facility design, procedures, personnel, processes, materials,