# FDA 483 - Davis City Pharmacy Inc. - February 18, 2022

Source: https://www.keypedia.com/records/483/davis-city-pharmacy-inc/060f5dac-73ca-481d-8fe8-4ad5e15c26f2

> FDA 483 for Davis City Pharmacy Inc. on February 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Davis City Pharmacy Inc.
- Inspection Date: 2022-02-18
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: During an FDA inspection from February 15-18, 2022, Davis City Pharmacy Inc., a producer of non-sterile drug products located at 111 Trinity St, Weatherford, TX, was cited for five observations. The inspection was issued to Brandi M. Chane-Lee, Owner/Certified Pharmacy Technician.

**Key Observations:**

1.  **Inadequate Containment and Cleaning for Potent Drugs:** The firm produced highly potent and/or hazardous non-sterile drug products (creams and capsules containing hormones like Progesterone or Testosterone) on an open countertop without adequate containment, segregation, or proper cleaning procedures. A spill of Testosterone was observed, and the cleaning agent used (b)(4) lacked scientific justification for deactivating or decontaminating the hazard. The firm also used a non-pharmaceutical grade liquid detergent, (b)(4), for cleaning equipment, which is not scientifically justified for inactivating or removing potent/hazardous drug substances.

2.  **Unsealed Ceiling Tiles:** Loose, unsealed ceiling tiles with exposed wires were observed in the non-sterile "compounding lab" during drug preparation.

3.  **Lack of Final Product Testing:** The firm failed to conduct appropriate tests to determine the identity and strength of active ingredients in non-sterile drug products, specifically Benzocaine 20%, Lidocaine 10%, Tetracaine 10% Lot #09302

## Related Documents

- [483 - 2022-02-18](https://www.keypedia.com/records/483/davis-city-pharmacy-inc/88ffa640-edc5-4323-b796-0322878a4033)
- [UNTITLED_LETTER - 2022-02-17](https://www.keypedia.com/records/untitled_letter/davis-city-pharmacy-inc/7aac71cd-7ccf-49e1-9ea2-d38537ed41b1)
- [STATE_REFERRAL_LETTER - 2022-02-15](https://www.keypedia.com/records/state_referral_letter/davis-city-pharmacy-inc/5e1b96bf-5c2b-4689-8bb4-147f1919cf67)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/davis-city-pharmacy-inc/58bec70f-3f1a-4b46-93fd-c077a5620ac7

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