Solaris Pharmacy, Inc.February 26, 2020

FDA 483 - Solaris Pharmacy, Inc. - February 26, 2020

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Record Details

Solaris Pharmacy, Inc. in Decatur, TX, was inspected by the FDA from February 19-26, 2020, and received two observations. The inspection revealed issues with unsuitable cleaning agents for non-sterile drug production and the use of non-pharmaceutical grade components in compounded drugs. These findings indicate significant concerns regarding the quality and safety of the firm's non-sterile drug products.

Company: Solaris Pharmacy, Inc.
Inspection Date: February 26, 2020
Product Type: Drugs
Office: Dallas District Office
Person: Patty P. Kaewussdangkul (Investigator)

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ID · c1d6c1dc-d32b-4101-9df4-e2df6cf9469f