483
Hiers Enterprises, LLC dba Northwest Compounding PharmacyHiers Enterprises, LLC dba Northwest Compounding Pharmacy – FDA 483, Nov 10, 2021
Record Details
An FDA inspection of Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in Roseburg, OR, revealed significant deficiencies in the production of non-sterile drug products. Observations included inadequate containment and cleaning practices for hazardous and beta-lactam drugs, leading to potential cross-contamination. Additionally, personnel failed to change gloves frequently enough, further compromising product integrity.
- Inspection date
- November 10, 2021
- Product type
- drugs
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ID · 6d7cf07c-ae6f-4ff3-88dd-30e1a1e607bc
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