FDA 483 - Well Care Discount Pharmacy, LLC - June 27, 2018

During an inspection, the firm was cited for three observations.

Observation 1 notes that drug products failing to meet established specifications are not rejected. Specifically, Testosterone 2mg/gram cream, lot 02092017:71@29, with a potency of 126% (outside the 90-110% range), was distributed to 3 patients without confirmed notification. Additionally, the firm does not routinely perform potency testing and has not tested any drug products produced since August 2017.

Observation 2 indicates a failure to reject components not meeting written specifications. The firm used Domperidone BP lot [redacted] (labeled "FOR VETERINARY USE ONLY") to produce Domperidone 20mg and 10mg capsules for human consumption on March 27, 2017, June 27, 2017, and December 8, 2017. These capsules were distributed as part of prescriptions [redacted] and [redacted].

Observation 3 states that laboratory controls do not include determining conformance to written specifications for component acceptance. The firm uses non-compendial grade [redacted] water, purchased from [redacted] stores, for drug product production (e.g., Dyclonine 1% Oral Solution, lot #04202018:35@19).