# FDA 483 - Avella  of Deer Valley dba Avella Specialty Pharmacy - February 25, 2013

Source: https://www.globalkeysolutions.net/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/85506ea4-1131-4db7-956b-8553950e72f5

> FDA 483 for Avella  of Deer Valley dba Avella Specialty Pharmacy on February 25, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avella  of Deer Valley dba Avella Specialty Pharmacy
- Inspection Date: 2013-02-25
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details significant deficiencies at a sterile drug product manufacturing facility.

**Gowning and Personnel:**
- Technicians wore non-sterile gowns with exposed skin (eyes, neck) in ISO 7 cleanrooms, violating SOP 03 S-32.
- Sterile gloves were donned in the ISO 7 ante-room, then used to wipe down ISO 5 Biosafety cabinets before aseptic processing, risking contamination.
- Operators' forearms, covered by non-sterile gowning, entered ISO 5 environments.
- Personnel monitoring (glove/fingertip sampling) was infrequent, not conducted after every lot.

**Environmental Monitoring:**
- Inadequate routine viable and non-viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing. Monitoring was primarily static or by external contractors during certification.
- No monitoring of cleanroom pressure differentials during aseptic processing; only external contractor monitoring at static conditions.
- Insufficient frequency and rotation of surface environmental monitoring in ISO 5 and ISO 7 cleanrooms, not sampling every surface or after each lot.

**Sterilization and Water Systems:**
- No written SOP for the in-house sterilization equipment (e.g., for vials); verbal on-the-job training only.
- Lack of routine monitoring (e.g., temperature display/recording, data charts) for each sterilization run, only periodic biological indicator processing.
- No firm

## Related Documents

- [483 - 2013-02-25](https://www.globalkeysolutions.net/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/f437d396-bb05-45d4-9fe3-93e296a831ac)
- [483 - 2015-07-31](https://www.globalkeysolutions.net/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/c0696580-ff5c-4f5e-a318-473b363c9bc0)
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## Related Officers

- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)
- [Investigator](https://www.globalkeysolutions.net/people/sonia-r-peterson/8acec5ae-f513-4c11-81fa-94c3b9dbd01e)

Company: https://www.globalkeysolutions.net/companies/avella-of-deer-valley-dba-avella-specialty-pharmacy/e689b0f5-b1ed-4f51-be2f-3bfd18ffab7b

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