# FDA 483 - Dougherty's Pharmacy - July 01, 2019

Source: https://www.keypedia.com/records/483/doughertys-pharmacy/fd1e68d4-197d-49b7-af65-c8cf05b985a0

> FDA 483 for Dougherty's Pharmacy on July 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dougherty's Pharmacy
- Inspection Date: 2019-07-01
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Dougherty's Pharmacy in Dallas, TX, a producer of sterile and non-sterile drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate controls to prevent contamination during adjacent construction, poor aseptic technique posing a risk to sterile drug processing, and a failure to conduct media fill studies under worst-case conditions. These issues indicate a lack of control over the manufacturing environment and processes, potentially compromising product quality and sterility.

## Related Documents

- [483 - 2015-12-29](https://www.keypedia.com/records/483/doughertys-pharmacy/b58120dc-8dae-480d-8752-ced061ea9e61)
- [483 - 2019-07-01](https://www.keypedia.com/records/483/doughertys-pharmacy/c391f3a6-0147-4172-a89d-ef7dd0bbb66c)
- [STATE_REFERRAL_LETTER - 2019-06-19](https://www.keypedia.com/records/state_referral_letter/doughertys-pharmacy/6ac34bd4-15ec-4d4d-a648-734f9e9d24e0)
- [145 - 2020-05-18](https://www.keypedia.com/records/145/doughertys-pharmacy/c9db7513-e909-4d89-9613-30d581dec968)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/doughertys-pharmacy/b40ecee7-f90f-4e5e-a7b5-cf4c798567a7

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9