# FDA 483 - Pharmacy Resources Incorporated - January 29, 2019

Source: https://www.keypedia.com/records/483/pharmacy-resources-incorporated/cb37072b-a808-4b92-9fdc-c3c2bc97b888

> FDA 483 for Pharmacy Resources Incorporated on January 29, 2019. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharmacy Resources Incorporated
- Inspection Date: 2019-01-29
- Office Name: Denver District Office
- Summary: The FDA Form 483 documents deficiencies at a facility producing sterile, intrathecal, and epidural drug products for human use, and sterile veterinary drugs. The facility utilizes ISO-5 workstations within an ISO-7 cleanroom.

Key observations include:
1.  **Aseptic Processing Area Deficiencies:**
    *   Cleaning and disinfection system for ISO-5 and ISO-7 areas is inadequate.
    *   Sporicidal disinfectant use is inconsistent and not routinely applied to ISO-7 cleanroom surfaces (floors, walls, ceilings).
    *   Cleaning records for ISO-5 workbenches between June 1, 2018, and December 30, 2018, incorrectly documented disinfectant use, and the disinfectant's sporicidal properties were not confirmed.
    *   Non-sterile cleaning wipes are used in ISO-5 workbenches.
    *   Non-cleanable items (clock radio, wall-mounted intercom) were present in the ISO-7 cleanroom.

2.  **Sterilization Process Validation:**
    *   No in situ air pattern analysis (smoke studies) conducted under simulated normal operating conditions in cleanrooms, laminar-flow hoods, or biosafety cabinets.

3.  **Protective Apparel:**
    *   Non-sterile shoe covers, bouffant hair covers, face masks/shields, and gowns (sprayed with non-sterile solution

## Related Documents

- [483 - 2017-05-23](https://www.keypedia.com/records/483/pharmacy-resources-incorporated/b11a1d34-2e4b-47c4-bfba-0a73d9b6a9d7)
- [WARNING_LETTER - 2017-05-23](https://www.keypedia.com/records/warning_letter/pharmacy-resources-incorporated/878175cd-7e0d-418c-a0e4-7ef668f5ebc4)
- [483 - 2019-01-29](https://www.keypedia.com/records/483/pharmacy-resources-incorporated/1b0abb98-54f8-4e3b-8f38-5e6523a8ac8f)
- [145 - 2020-03-25](https://www.keypedia.com/records/145/pharmacy-resources-incorporated/b0d585f5-0019-4f1f-bef8-900be2c64e5d)

## Related Officers

- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.keypedia.com/companies/pharmacy-resources-incorporated/0c3af1ab-aebc-4d3b-a427-236a0a62eaa2

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face