Pharmcore Inc. dba Hallandale Pharmacy – FDA Warning Letter, Jul 13, 2018

On March 11, 2020, the FDA issued a Warning Letter to Pharmcore Inc., dba Hallandale Pharmacy, following an inspection from July 2-13, 2018, at their Hallandale, Florida facility. The inspection revealed serious deficiencies in sterile drug product production, posing patient risks.

Key violations include: - **Failure to meet Section 503A conditions:** The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drug products (e.g., Benzocaine/Lidocaine/Tetracaine Cream, Trimix 5ML Vial), rendering them ineligible for exemptions from CGMP, adequate labeling, and FDA approval. - **Adulterated Drug Products (Section 501(a)(2)(A)):** Sterile drug products were prepared under insanitary conditions. Deficiencies included: - Facility design allowing influx of lesser quality air into higher quality areas (e.g., power turned off to sterile suite during cleaning, holes in ISO-7 walls, unsealed hole in ISO-5 BSC). - Inadequate smoke studies under dynamic conditions, showing non-unidirectional airflow in ISO-5 areas. - Poor facility maintenance (visible debris/stains/rust in ISO-5 BSC and prep table, dirt on HEPA filter covers). - Cleaning equipment not maintained (fraying, particle-generating mop heads).