pharmacy plus, inc. – FDA Warning Letter, Jul 7, 2016

The FDA issued a Warning Letter to Vital Care Compounder, LLC, following a June 3 to July 7, 2016, inspection prompted by an adverse event report linked to their chloral hydrate oral solution. The inspection revealed the firm produced drug products failing to meet Section 503A of the FDCA conditions for exemption from certain provisions, including CGMP, adequate labeling, and FDA approval.

Violations included: - **Failure to meet Section 503A conditions:** Compounding without valid patient-specific prescriptions and using domperidone, a bulk drug substance not eligible for 503A exemptions. - **Adulterated drug products:** A chloral hydrate oral solution was found to contain 980% of its labeled concentration. Sterile drug products were prepared under insanitary conditions, including an unclassified aseptic processing room, a shattered ISO 5 hood, improper storage of sterilized items, and inadequate disinfection practices (no sporicidal agent or sterile wipes). - **CGMP violations:** Failure to maintain equipment for aseptic conditions, lack of validated aseptic/sterilization procedures, inadequate cleaning/disinfection, no time limits for production phases, insufficient environmental monitoring, and an inadequate quality control unit. - **Unapproved new drug products:** Ineligible drug products were marketed without FDA approval. - **Misbranded drug products:** Ineligible drug products lacked adequate directions for use, and the chloral hydrate product's labeling