FDA WARNING_LETTER - JCB Laboratories LLC - February 27, 2013

The FDA issued a Warning Letter to JCB Labs, LLC, following an inspection from February 12-27, 2013, prompted by adverse event reports related to repackaged Propoven (propofol) 1%. The inspection revealed serious deficiencies in sterile drug product practices, risking contamination.

Key violations include: 1. **Adulteration Charges (Section 501(a)(2)(A) FDCA):** The firm's sterile drug products were prepared, packed, or held under insanitary conditions. Specifically, SOP 3.030 for cleanroom cleaning specified non-sterile disinfectants and did not require sterile cleaning pads/towels or sporicidal agents for ISO-5 areas. This could lead to contamination, rendering products injurious to health. 2. **Misbranding Charges (Section 502(g) FDCA):** The firm failed to package and store propofol 1% according to the USP monograph, which requires tight containers under an inert atmosphere. During repackaging, the source vial was vented to the pharmacy atmosphere without assessing the impact on product quality. This deviation from compendial standards causes the drug to be misbranded.

The FDA cited these as prohibited acts under Sections 301(a) and 301(k) of the FDCA. Although JCB Labs registered as a 503B outsourcing facility on January 21,