# FDA 483 - Pharmcore Inc. dba Hallandale Pharmacy - September 24, 2021

Source: https://www.globalkeysolutions.net/records/483/pharmcore-inc-dba-hallandale-pharmacy/acebae09-a033-4833-b393-669e6b043f1d

> FDA 483 for Pharmcore Inc. dba Hallandale Pharmacy on September 24, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmcore Inc. dba Hallandale Pharmacy
- Inspection Date: 2021-09-24
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Pharmcore Inc. dba Hallandale Pharmacy, a producer of sterile and non-sterile drugs located at 2666 SW 36th St, Fort Lauderdale, FL, was conducted from September 13-24, 2021. The inspection identified three observations.

Observation 1 noted inadequate cleaning procedures to prevent cross-contamination. Specifically, the firm cleans the sterile hazardous compounding suite before the sterile non-hazardous suite, which could introduce hazardous materials into the non-hazardous area. Additionally, the technician does not re-gown between cleaning these suites.

Observation 2 indicated a failure to take remedial action when actionable microbial contamination was found in ISO 5 classified aseptic processing areas during production. The firm's QA Director stated a thorough clean is conducted only for objectionable microorganisms, but not for all actionable microbial contamination. Examples cited include *Staphylococcus epidermidis* isolated from an ISO5 biosafety cabinet (BSC) and laminar air flow hood (LAFH) on March 29, 2021; *Micrococcus luteus* from an ISO5 BSC on April 26, 2021; and *Bacillus megaterium* from an ISO5 BSC on April 8, 2021.

Observation 3 detailed that materials or supplies were not disinfected prior to entering aseptic processing areas. On September 15, 2021, a

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pharmcore-inc-dba-hallandale-pharmacy/3cfc388f-8861-4cad-9bff-dc101ad7d028

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