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

Source: https://www.keypedia.com/records/483/medoz-pharmacy-of-polk-inc/1adee83f-44bb-42c1-b0c8-380139fc1408

> FDA 483 for Medoz Pharmacy of Polk Inc on August 27, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medoz Pharmacy of Polk Inc
- Inspection Date: 2021-08-27
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: 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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## Related Documents

- [483 - 2019-08-09](https://www.keypedia.com/records/483/medoz-pharmacy-of-polk-inc/008cc044-18cd-417d-aeb1-4bde0dc7647b)
- [WARNING_LETTER - 2019-08-09](https://www.keypedia.com/records/warning_letter/medoz-pharmacy-of-polk-inc/661b99be-7fea-478e-903d-da905f0d3a32)
- [483 - 2021-08-27](https://www.keypedia.com/records/483/medoz-pharmacy-of-polk-inc/89952303-1028-47dc-8cc9-c15850ff1a8e)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.keypedia.com/companies/medoz-pharmacy-of-polk-inc/7b329d4d-a4cb-40e9-bd4c-57aa3d55d6b3

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9