# FDA 483 - Promise Pharmacy, LLC - October 25, 2018

Source: https://www.keypedia.com/records/483/promise-pharmacy-llc/8eca5a8a-da83-49b2-8397-90046d46a4e4

> FDA 483 for Promise Pharmacy, LLC on October 25, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Promise Pharmacy, LLC
- Inspection Date: 2018-10-25
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483, issued to Mipal (Amy) Patel, Pharmacist-In-Charge at Promise Pharmacy, LLC, a producer of sterile and non-sterile products located at 31818 Us Highway 19 N, Palm Harbor, FL, details observations from an inspection conducted between October 15-25, 2018.

**Key Observations:**

1.  **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products were inadequate. Specific instances included an operator blocking HEPA filtered air and not moving slowly in the ISO 5 environment during Bremelanotide production, and an operator not wearing a beard cover during HCG Injectable production.
2.  **Quality Control Unit Deficiencies:** The quality control unit lacked responsibility for approving/rejecting procedures impacting drug product quality. The firm did not visually examine finished drug products before dispensing, leading to observed particulates in distributed Prednisolone and Gatifloxacin Ophthalmic Solution.
3.  **Contamination Prevention in Facility Design:** The flow of materials and the environment were not designed to prevent contamination. The sterile non-hazardous production environment did not meet ISO 5 standards due to incomplete HEPA filter coverage, lack of full pressure differential assessment, unperformed smoke studies throughout the room, and a non-classified pass-through from the ISO 8 Prep room to the ISO 5 sterile environment. Additionally, partially stoppered vials were

## Related Documents

- [483 - 2018-10-25](https://www.keypedia.com/records/483/promise-pharmacy-llc/15106ddd-d369-40cd-b97d-f3446b2f99db)
- [WARNING_LETTER - 2018-10-25](https://www.keypedia.com/records/warning_letter/promise-pharmacy-llc/64828c32-eacf-45eb-b693-4cb228cbc1de)
- [483 - 2021-09-23](https://www.keypedia.com/records/483/promise-pharmacy-llc/1fd494b0-82d0-4850-8ef7-13a0159237a2)
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- [STATE_REFERRAL_LETTER - 2021-08-30](https://www.keypedia.com/records/state_referral_letter/promise-pharmacy-llc/341a0126-147d-4055-93c2-66822d502b39)

## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/promise-pharmacy-llc/ab8cc9f6-dafc-4781-8982-9f88ee1920e3

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