483
Customceutical CompoundingCustomceutical Compounding – FDA 483, Mar 8, 2019
Record Details
Customceutical Compounding, LLC in Phoenix, AZ, was inspected regarding its production of sterile and non-sterile drugs. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, personnel gowning, and cleaning procedures for sterile products. Additionally, the firm failed to prevent cross-contamination during the production of hazardous non-sterile drug products.
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ID · 4f701361-2ae3-4f4d-827f-0be98cd0d102
Violation Codes3
21 CFR 21121 CFR 331(c)21 CFR 210
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