Lowlite Investments, Inc. D/B/A Olympia Pharmacy – FDA Warning Letter, Mar 21, 2013

On February 18, 2014, the FDA issued a Warning Letter to Lowlite Investments, Inc., D/B/A Olympia Pharmacy, following an inspection from March 4 to March 21, 2013. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations include: 1. **Lack of Valid Prescriptions:** The firm produced drug products without receiving valid prescriptions for individually identified patients, violating FDCA Section 503A and rendering these drugs unapproved new drugs (Section 505(a)) and misbranded (Section 502(f)(1)). 2. **Domperidone Production:** The firm produced domperidone drug products, which are not subject to an applicable USP/NF monograph, are not components of FDA-approved human drugs, and are not on a Secretary-developed list, making them misbranded (Section 502(f)(1)). 3. **Insanitary Conditions and Adulteration:** Serious deficiencies in sterile drug product manufacturing practices were observed, leading to the recall of all sterile products produced before March 27, 2013. Observations included personnel with torn gloves and exposed skin touching uncapped vials, opening stoppers onto non-sterile surfaces, transferring products without ISO-5 protection, using non-sterile disinfectants without sporicidal agents, and failing to routinely