# FDA WARNING_LETTER - Pharmcore Inc. dba Hallandale Pharmacy - July 13, 2018

Source: https://www.keypedia.com/records/warning_letter/pharmcore-inc-dba-hallandale-pharmacy/007b955e-8a06-431e-a09a-c4c09be23f85

> FDA WARNING_LETTER for Pharmcore Inc. dba Hallandale Pharmacy on July 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pharmcore Inc. dba Hallandale Pharmacy
- Inspection Date: 2018-07-13
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: On March 11, 2020, the FDA issued a Warning Letter to Pharmcore Inc., dba Hallandale Pharmacy, following an inspection from July 2-13, 2018, at their Hallandale, Florida facility. The inspection revealed serious deficiencies in sterile drug product production, posing patient risks.

Key violations include:
- **Failure to meet Section 503A conditions:** The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drug products (e.g., Benzocaine/Lidocaine/Tetracaine Cream, Trimix 5ML Vial), rendering them ineligible for exemptions from CGMP, adequate labeling, and FDA approval.
- **Adulterated Drug Products (Section 501(a)(2)(A)):** Sterile drug products were prepared under insanitary conditions. Deficiencies included:
    - Facility design allowing influx of lesser quality air into higher quality areas (e.g., power turned off to sterile suite during cleaning, holes in ISO-7 walls, unsealed hole in ISO-5 BSC).
    - Inadequate smoke studies under dynamic conditions, showing non-unidirectional airflow in ISO-5 areas.
    - Poor facility maintenance (visible debris/stains/rust in ISO-5 BSC and prep table, dirt on HEPA filter covers).
    - Cleaning equipment not maintained (fraying, particle-generating mop heads).

## Related Documents

- [483 - 2018-07-13](https://www.keypedia.com/records/483/pharmcore-inc-dba-hallandale-pharmacy/70e70f73-d649-4219-b0c5-973fd1e722ef)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/pharmcore-inc-dba-hallandale-pharmacy/6257448b-1c45-4d99-bd0f-17dcc715705c)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/pharmcore-inc-dba-hallandale-pharmacy/acebae09-a033-4833-b393-669e6b043f1d)
- [STATE_REFERRAL_LETTER - 2021-09-13](https://www.keypedia.com/records/state_referral_letter/pharmcore-inc-dba-hallandale-pharmacy/5c6dfc57-c2d7-44c9-a9f5-f7af63976eaa)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/pharmcore-inc-dba-hallandale-pharmacy/e6cd5274-1edc-42cd-944a-50436426a62c)

## Related Officers

- [Renee Alsobrook](https://www.keypedia.com/people/renee-alsobrook/2ecfa488-4a0e-46bd-af85-a5a43456f225)
- [Medhat Mettias](https://www.keypedia.com/people/medhat-mettias/a6ef8503-e0df-4347-ab65-5929e0bb6d2a)
- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da