# FDA 483 - Fairview Compounding Pharmacy - April 18, 2018

Source: https://www.keypedia.com/records/483/fairview-compounding-pharmacy/36d9515f-f433-4ad2-97c5-300e2a5f2377

> FDA 483 for Fairview Compounding Pharmacy on April 18, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fairview Compounding Pharmacy
- Inspection Date: 2018-04-18
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Fairview Compounding Pharmacy, a producer of sterile and non-sterile products located at 711 Kasota Ave SE, Minneapolis, MN, was conducted from April 2, 2018, to April 18, 2018. The inspection identified six observations regarding the firm's operations.

Observation 1 noted the use of non-sterilized and non-depyrogenated equipment in sterile drug production. Specifically, non-sterile aluminum foil was used to cover a non-sterile product and transported into the ISO 5 aseptic processing area, where it was removed, and aseptic processing of Triple Agent UTZ injectable product (lot #180403-28) continued. Papaverine and phentolamine mesylate stock solutions were produced in an unclassified non-sterile area, and depyrogenated glassware was also stored there.

Observation 2 indicated inadequate use of sporicidal agents in cleanrooms and the ISO 5 aseptic processing area. Cleaning of ISO 5 areas on April 3rd, 2018, and deep cleaning of ISO 5 and 7 areas on April 6th, 2018, were performed without sporicidal agents, and the firm does not use them regularly.

Observation 3 detailed instances where personnel did not disinfect and change gloves frequently enough. On April 2, 2018, an employee producing allergy

## Related Documents

- [145 - 2019-04-29](https://www.keypedia.com/records/145/fairview-compounding-pharmacy/0e048c67-55f7-46b5-8fbf-94122162a42c)
- [STATE_REFERRAL_LETTER - 2018-04-09](https://www.keypedia.com/records/state_referral_letter/fairview-compounding-pharmacy/11a74d29-a9bb-4cd0-a27b-56659fefe658)
- [483 - 2018-04-18](https://www.keypedia.com/records/483/fairview-compounding-pharmacy/0a67a8b1-bb80-47fd-a587-321e81716b88)

## Related Officers

- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Pharmacist at U.S. Public Health Service Commissioned Corps](https://www.keypedia.com/people/anthony-j-ladner/dbb6b53a-80d1-4b47-ae42-6eb2053dfa4b)

Company: https://www.keypedia.com/companies/fairview-compounding-pharmacy/27cd1a8f-b6bd-4568-b65a-ce0915873993

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d