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

Source: https://www.keypedia.com/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/f437d396-bb05-45d4-9fe3-93e296a831ac

> 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 multiple deficiencies at a facility producing sterile drug products, observed during an inspection on February 19, 2013.

**Gowning and Aseptic Technique Deficiencies:**
*   Technicians wore non-sterile gowns with exposed skin (around eyes and neck) in the ISO 7 cleanroom, contrary to SOP 03-32.
*   Sterile gloves were donned in the ISO 7 ante-room, with operators observed contacting the outside of sterile gloves with bare hands.
*   Operators used non-sterile gloves to wipe down ISO 5 biosafety cabinets and materials, then proceeded to conduct aseptic processing with the same gloves after spraying and air drying, without donning new sterile gloves within the ISO 5 environment.
*   Operators' forearms, covered by non-sterile gowning, were exposed within the ISO 5 environment during aseptic operations.

**Environmental Monitoring Deficiencies:**
*   Lack of routine viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing (only static condition monitoring by outside contractor).
*   Lack of active non-viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing (only static condition monitoring during certification).
*   No active monitoring of differential pressures in cleanrooms during aseptic processing; only static condition monitoring.
*   Insufficient frequency of personnel monitoring (gloves/arms not sampled after every lot).

## Related Documents

- [483 - 2013-02-25](https://www.keypedia.com/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/85506ea4-1131-4db7-956b-8553950e72f5)
- [483 - 2015-07-31](https://www.keypedia.com/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/c0696580-ff5c-4f5e-a318-473b363c9bc0)
- [145 - 2017-02-15](https://www.keypedia.com/records/145/avella-of-deer-valley-dba-avella-specialty-pharmacy/f48f877d-2068-43aa-9fd6-06c01be010ef)
- [483 - 2018-04-19](https://www.keypedia.com/records/483/avella-of-deer-valley-dba-avella-specialty-pharmacy/64269105-59f2-44d9-a93a-754c84e74e58)

## Related Officers

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

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

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