# FDA 483 - SaveWay Compounding Pharmacy, Inc. - October 02, 2015

Source: https://www.keypedia.com/records/483/saveway-compounding-pharmacy-inc/bf2bd839-2148-45d6-b10e-a9ca3ac2ff51

> FDA 483 for SaveWay Compounding Pharmacy, Inc. on October 02, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SaveWay Compounding Pharmacy, Inc.
- Inspection Date: 2015-10-02
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA Form 483 documents significant deficiencies in aseptic processing and quality control at the inspected facility.

**Environmental Monitoring and Control:**
*   Routine/daily environmental or personnel monitoring (personnel, surface, air) is not performed during sterile compounding operations, only approximately every six months, lacking assurance of an aseptic environment.
*   The curtain separating the ISO Class 7 buffer-room from the ISO Class 7 ante-room has not been evaluated for microbial contamination, is not part of the environmental monitoring program, and lacks a written cleaning/sanitization procedure.
*   Positive pressure differential between the ISO Class 7 ante/buffer room and the adjacent unclassified segregated compound set-up room is not assured, as room pressure is not monitored in the segregated compounding room.

**Personnel Gowning and Practices:**
*   Cleanroom gowns are inappropriate for aseptic processing (porous, thin, see-through, easily torn), and their sterility is unassured, with no data to confirm the firm's sterilization process.
*   Gowning procedures lack requirements for hoods or goggles, leaving exposed skin on the neck and face. Facemasks used are not sterile.

**Sterilization and Aseptic Process Validation:**
*   Media fill simulations do not represent worst-case conditions, lacking requirements for performance after compounding operations/steps or with maximum personnel.
*   Smoke studies for the ISO Class 7 buffer-room only evaluated static air-flow

## Related Documents

- [483 - 2017-06-29](https://www.keypedia.com/records/483/saveway-compounding-pharmacy-inc/75946c5d-4010-4674-9b27-4f1460bd1226)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/paul-l-bellamy/e94e1ff9-0772-4c1f-af99-a8298983e2f4)

Company: https://www.keypedia.com/companies/saveway-compounding-pharmacy-inc/100f3332-689c-4c8c-b1c3-d1bb280ef860

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8