# FDA 483 - Medoz Pharmacy of Polk Inc - August 09, 2019

Source: https://www.keypedia.com/records/483/medoz-pharmacy-of-polk-inc/008cc044-18cd-417d-aeb1-4bde0dc7647b

> FDA 483 for Medoz Pharmacy of Polk Inc on August 09, 2019. 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: 2019-08-09
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 was issued to Medoz Pharmacy of Polk Inc, a producer of sterile and non-sterile drugs, located at 40230 Highway 27 Ste 100, Davenport, FL 33837-7807. The inspection was conducted from July 30, 2019, to August 9, 2019, and the report was issued to Tushar Palan, MS, RPh, Partial Owner & Pharmacist in Charge.

The inspection revealed 14 observations:

1.  **Inadequate Cleaning for Hazardous Drugs:** The firm produced hazardous drugs (Chorionic Gonadotropin and Cyclosporin) on the same day without evidence of cleaning between batches or identifying the ISO 5 BSC used, leading to potential cross-contamination.
2.  **Vermin in Production Area:** Numerous dead ants were observed in the clean room (sterile drug production) and non-sterile suite (non-sterile drug production). Household spray was used, and no pest control records were provided.
3.  **Vermin Adjacent to Production Area:** Dead spiders, cockroaches, and ants were found in the anteroom, on sterile stopper packaging in an unclassified area, and in hallways leading to the non-sterile suite. Living spiders were also observed.
4.  **Dirty ISO 5 Aseptic Processing Areas:** The Bio-Safety Cabinet ISO

## Related Documents

- [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)
- [483 - 2021-08-27](https://www.keypedia.com/records/483/medoz-pharmacy-of-polk-inc/1adee83f-44bb-42c1-b0c8-380139fc1408)

## 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