FDA 483 - Medoz Pharmacy of Polk Inc - August 27, 2021

This FDA Form 483 document details observations made during an inspection of a facility's non-sterile hazardous and non-hazardous production areas.

**Facility and Operation Details:** The inspection took place on August 23, 2021, focusing on production areas for non-sterile hazardous and non-hazardous products. The firm utilizes a pest control service, (b) (4), which uses (b) (4) (Active Ingredient: (b) (4)).

**Violations and Observations:** * **Vermin in Production Area:** Numerous dead ants were observed along the corners of the walls within both the non-sterile hazardous and non-hazardous production areas on August 23, 2021. * **Pest Control Service Findings:** On July 31, 2021, the firm's pest control service noted unsealed exterior cracks and crevices. * **Structural Deficiencies:** A door in the non-sterile hazardous production area, which leads directly to the outside, was observed to have a (b) (4) gap at the bottom. This gap is identified as a potential entry point for ants.

**Critical Findings/Deficiencies:** The presence of vermin (ants) in the production area, coupled with unaddressed structural issues (unsealed cracks/crevices and a door gap), indicates a failure in maintaining a clean and controlled environment suitable for manufacturing.

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