483
Vortech Pharmaceuticals LtdVortech Pharmaceuticals Ltd – FDA 483, Nov 6, 2024
Record Details
Vortech Pharmaceuticals, Ltd in Dearborn, MI, was inspected and cited for significant deficiencies across multiple areas. Observations included inadequate cleaning, maintenance, and documentation of drug manufacturing equipment, as well as insufficient laboratory controls for water testing, specifically lacking validated methods for detecting Burkholderia cepacia Complex. Additionally, the firm failed to maintain proper records and procedures for returned drug products.
- Office
- Detroit District Office
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ID · d8237f2e-798f-4395-bb33-b37e6485c820
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