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

Source: https://www.keypedia.com/records/483/pharmacy-resources-incorporated/1b0abb98-54f8-4e3b-8f38-5e6523a8ac8f

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

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## Details

- Record Type: 483
- Company Name: Pharmacy Resources Incorporated
- Inspection Date: 2019-01-29
- Office Name: Denver District Office
- Summary: An FDA inspection of Pharmacy Resources Incorporated, a producer of sterile and non-sterile drug products, was conducted from January 9 to January 29, 2019. The inspection revealed several significant deficiencies, many of which were repeat observations, indicating non-adherence to Good Manufacturing Practices.

Key violations included: inadequate cleaning and disinfection systems for aseptic processing areas, with unvalidated disinfectants, non-sterile cleaning materials, and unapproved items in cleanrooms; a lack of validated sterilization processes, specifically in situ air pattern analyses; and insufficient protective apparel for personnel, leading to contamination risks. Additionally, the firm was cited for exposing sterile vials to less controlled environments before aseptic processing, lacking a written stability testing program for finished drug products, and failing to conduct adequate method suitability testing for in-house sterility tests. The environmental monitoring program for aseptic areas was also found to be deficient, with infrequent monitoring and a lack of investigation into positive results.

These observations necessitate that Pharmacy Resources Incorporated implement comprehensive corrective and preventive actions to ensure the quality, safety, and purity of its drug products.

## 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/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

- [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