# FDA 483 - Avella Specialty Pharmacy - April 19, 2018

Source: https://www.keypedia.com/records/483/avella-specialty-pharmacy/f901e1b4-76ac-4d8c-abd7-fd576ff5846f

> FDA 483 for Avella Specialty Pharmacy on April 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avella Specialty Pharmacy
- Inspection Date: 2018-04-19
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details observations from an inspection of Avella Specialty Pharmacy, an outsourcing facility.

**Violations and Observations:**

1.  **Failure to Fully Follow Quality Control Unit Procedures:**
    *   **Vendor Qualification:** The firm's SOPs (03HV05-GEN-011 and 03HV05-039) for vendor qualification were not followed.
        *   Seven out of fourteen vendors supplying drug components, container closures, and testing/monitoring services were not qualified.
        *   Two vendors qualified in 2013 and one in 2014 had not been re-qualified every (b)(4) as required by SOPs.
        *   Qualified vendors lacked complete documentation, including form GF-27 Vendor Qualification Questionnaire and/or form QF-03 Outside Lab Quality Audit.
        *   The firm failed to collect licensing, accreditations, and FDA registration for several vendors.
        *   In 2017, (b)(4) units of Bevacizumab were compounded and distributed using materials from unqualified vendors and tested by these vendors.
    *   **Analytical Lab Qualification Audit Follow-up:** The quality unit failed to follow up on deficiencies observed during analytical lab qualification audits.
        *   For example, (b)(4) was approved as a qualified supplier in 2013 despite five "Needs

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.keypedia.com/companies/avella-specialty-pharmacy/b7283d9c-fce3-404a-ad3a-416813456bad

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