# FDA 483 - HHCS Pharmacy Inc. - July 28, 2014

Source: https://www.keypedia.com/records/483/hhcs-pharmacy-inc/8459f80c-b04b-45f5-9ef6-aec178b0eb14

> FDA 483 for HHCS Pharmacy Inc. on July 28, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HHCS Pharmacy Inc.
- Inspection Date: 2014-07-28
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 was issued to HHCS Pharmacy, Inc. dba Freedom Pharmacy, a producer of sterile drug products located at 3901 E. Colonial Dr., Orlando, FL 32803-4602. The inspection occurred from July 14 to July 28, 2014.

The inspection revealed eight observations:

1.  **Inadequate Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation. Specifically, syringe/dispensing systems used for liquid drug products from non-sterile components are not documented for sterilization, and there are no written procedures for process validation using media fill testing. A high-risk inhalation drug product (Vancomycin/Betamethasone/Tobramycin) was produced from non-sterile powders without proper validation. Media fill records for current sterile compounding technicians are incomplete or outdated.

2.  **Deficient Aseptic Processing Areas:**
    *   Rust was observed on a HEPA filter ceiling screen in the ISO 7 cleanroom.
    *   A kitchen-grade sink with an open drain is in the anteroom, adjacent to the pass-through box used for sterile product transport.
    *   No line of demarcation or designated gowning area exists near the ISO 7 cleanroom.
    *   Ceilings in the cleanroom and anteroom are not sealed; cracked, water-damaged, and porous ceiling tiles were

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-10-11](https://www.keypedia.com/records/state_referral_letter/hhcs-pharmacy-inc/e5f7b6c2-cac9-4220-8da9-a68a324f25b1)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Retired-FDA Compliance Officer, CDER](https://www.keypedia.com/people/carla-a-norris/90f059dd-f4cc-4599-b9c9-134465185c49)

Company: https://www.keypedia.com/companies/hhcs-pharmacy-inc/c25fcd3c-8a28-414d-ae27-9a0fc33c2383

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9