# FDA 483 - Promise Pharmacy, LLC - September 23, 2021

Source: https://www.keypedia.com/records/483/promise-pharmacy-llc/1fd494b0-82d0-4850-8ef7-13a0159237a2

> FDA 483 for Promise Pharmacy, LLC on September 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Promise Pharmacy, LLC
- Inspection Date: 2021-09-23
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Promise Pharmacy, LLC in Palm Harbor, FL, was inspected and received a Form 483 with two observations. The inspection revealed the routine use of non-pharmaceutical grade components in the formulation of both sterile and non-sterile drug products. Additionally, personnel were observed failing to maintain aseptic technique by not changing or sanitizing gloves after touching non-ISO 5 surfaces before returning to aseptic processing.

## Related Documents

- [483 - 2018-10-25](https://www.keypedia.com/records/483/promise-pharmacy-llc/8eca5a8a-da83-49b2-8397-90046d46a4e4)
- [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/41a552f9-b9dc-4a86-9b0e-e877735acc55)
- [STATE_REFERRAL_LETTER - 2021-08-30](https://www.keypedia.com/records/state_referral_letter/promise-pharmacy-llc/341a0126-147d-4055-93c2-66822d502b39)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

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

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea