FDA WARNING_LETTER - Compound Preferred LLC - March 01, 2017

On October 27, 2017, the FDA issued a Warning Letter to RAM Pharma, Inc., an outsourcing facility registered under section 503B of the FDCA. An inspection from February 7 to March 1, 2017, revealed serious deficiencies in sterile drug production and failure to meet 503B conditions, rendering products adulterated and misbranded.

Violations included: - **Failure to meet 503B conditions:** Drug labels lacked required statements (e.g., "This is a compounded drug," quantity/volume, adverse event reporting info, ingredient lists). The facility also failed to submit initial and complete drug product reports in July and December 2016. - **Adulterated Drug Products (Insanitary Conditions):** The ISO-5 hood was constructed of unfinished particle board, 19 lots of sterile products were released from an uncertified ISO-5 hood, an industrial vacuum was used in the ISO-7 clean room before production, media fills were not conducted, and non-sterile wipes were used in the ISO-5 hood. - **Adulterated Drug Products (CGMP Violations):** Failures included maintaining aseptic equipment, establishing procedures to prevent microbiological contamination, cleaning/disinfecting rooms/equipment, testing for final specifications (sterility/endotoxins), ensuring appropriate personnel gowning, and establishing stability testing programs. - **Misbranded Drug