# FDA 483 - Dougherty's Pharmacy - December 29, 2015

Source: https://www.keypedia.com/records/483/doughertys-pharmacy/b58120dc-8dae-480d-8752-ced061ea9e61

> FDA 483 for Dougherty's Pharmacy on December 29, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dougherty's Pharmacy
- Inspection Date: 2015-12-29
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 was issued to Dougherty's Pharmacy, a producer of sterile drug products in Dallas, TX, on December 29, 2015, following an inspection from December 8-29, 2015. The document lists twelve observations indicating significant deficiencies in their manufacturing and quality control processes for sterile drug products.

Key violations include:
*   **Lack of Sterility and Endotoxin Testing:** Numerous sterile and non-sterile to sterile products, including Alprostadil USP, were released without sterility testing from June to September 2015. The in-house sterility test method used was unvalidated, and endotoxin testing was not performed for non-sterile to sterile products. Non-sterile products with extended Beyond Use Dates (BUDs) lacked sterility testing and verification.
*   **Inadequate Product Testing and Release:** The firm failed to conduct potency testing for 111 batches of sterile finished products released between June and December 2015, many with BUDs of 90-180 days. Preservative content testing was also not performed for sterile formulations containing preservatives.
*   **Deficient Laboratory Controls:** The product inspection process lacked 100% visual checks against a contrasting background for sterile liquid formulations, and no written procedure for visual checks existed.
*   **Poor Environmental Monitoring and Aseptic Practices:** No environmental monitoring (air, personnel,

## Related Documents

- [483 - 2019-07-01](https://www.keypedia.com/records/483/doughertys-pharmacy/fd1e68d4-197d-49b7-af65-c8cf05b985a0)
- [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/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
- [Ademola O. Daramola](https://www.keypedia.com/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)

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