# FDA 483 - Pharmacy Resources Incorporated - May 23, 2017

Source: https://www.keypedia.com/records/483/pharmacy-resources-incorporated/b11a1d34-2e4b-47c4-bfba-0a73d9b6a9d7

> FDA 483 for Pharmacy Resources Incorporated on May 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacy Resources Incorporated
- Inspection Date: 2017-05-23
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility compounding sterile drug products, including Tri-Mix Injectable and erectile dysfunction sterile drug products.

Key observations include:
1.  **Aseptic Processing Area Deficiencies:** Inadequate cleaning agents (expired sporicidal agent, unestablished disinfectant efficacy, insufficient contact time for sanitizing agents). Non-smooth, porous surfaces (speakers, stereo, intercom) were present in the ISO 7 cleanroom/buffer area.
2.  **Environmental Monitoring Deficiencies:** Monitoring is not representative of daily sterile operations. Personnel monitoring is infrequent and limited. Viable air and surface monitoring of ISO 5 areas is only performed quarterly. Positive environmental monitoring results from 2016 and 2017 were not investigated, and alert/action limits were not determined. Missing environmental data for specific hoods and locations were also not investigated.
3.  **Sterilization Process Validation:** No in situ air pattern analyses (smoke studies) were conducted under dynamic conditions for cleanrooms, laminar-flow hoods, or (b)(4), lacking assurance of critical processing area suitability.
4.  **Stability Testing:** No written program or finished product sterility data to support expiration dates for erectile dysfunction sterile drug products.
5.  **Protective Apparel:** Inadequate non-sterile cleanroom garb (shoe covers, hair net, face mask/shield) was worn by technicians performing aseptic filling in the ISO 5 zone

## Related Documents

- [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)
- [483 - 2019-01-29](https://www.keypedia.com/records/483/pharmacy-resources-incorporated/cb37072b-a808-4b92-9fdc-c3c2bc97b888)
- [145 - 2020-03-25](https://www.keypedia.com/records/145/pharmacy-resources-incorporated/b0d585f5-0019-4f1f-bef8-900be2c64e5d)

## Related Officers

- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

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