# FDA 483 - Banner Pharmacy Services, LLC - September 20, 2017

Source: https://www.keypedia.com/records/483/banner-pharmacy-services-llc/62a81eb6-439c-423e-88ea-9d5c9517c77e

> FDA 483 for Banner Pharmacy Services, LLC on September 20, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Banner Pharmacy Services, LLC
- Inspection Date: 2017-09-20
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 details numerous deficiencies observed during an inspection of a sterile and non-sterile drug product manufacturing facility.

**Facility and Operations:** The facility compounds sterile drug products like Lidocaine HCl, Oxytocin, Vancomycin, and Total Parenteral Nutrition (TPN), as well as non-sterile oral Vancomycin HCL and GI cocktail oral suspension. The inspection covered ISO 5 laminar hoods, ISO 7 non-hazardous compounding rooms, ISO 8 anterooms (gowning areas), and ISO 8 prep areas.

**Violations and Observations:**
*   **Quality Control Unit Deficiencies:** The quality control unit lacked authority to reject drug products, specifically releasing batches of sterile drug product that failed potency and particulate matter specifications without adequate justification.
*   **Stability and Expiration Dates:** Beyond-use dates (BUDs) for sterile drug products were not assigned based on adequate stability testing, with failing stability results disregarded.
*   **Aseptic Processing Area Deficiencies:**
    *   **Air Filtration:** Leaks were found in HEPA filters in the ISO 7 and ISO 8 cleanrooms during (b)(4) testing in 2016 and 2017. Manufacturing continued for nearly a year without investigation into potential sterility compromise.
    *   **Cleaning and Disinfection:** The firm uses (b)(4) as a sporicidal disinfectant but lacks scientific data to ensure its effectiveness

## Related Documents

- [483 - 2015-03-20](https://www.keypedia.com/records/483/banner-pharmacy-services-llc/08be8a1a-2265-48fc-acab-57d9d36b19a6)
- [483 - 2019-10-08](https://www.keypedia.com/records/483/banner-pharmacy-services-llc/1c73b59b-5526-4216-be08-5b742cd13c02)
- [STATE_REFERRAL_LETTER - 2019-10-05](https://www.keypedia.com/records/state_referral_letter/banner-pharmacy-services-llc/496ff734-c3ab-491c-adda-1ff0cbced39d)

## Related Officers

- [Ashar Parikh Investigator](https://www.keypedia.com/people/ashar-parikh-investigator/0bc5966b-270b-4ad3-9ad9-9919fd7b0003)
- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/banner-pharmacy-services-llc/7badd15e-f0c8-4662-beae-42e03bd61811

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b