483
Procos S.p.A.FDA 483 - Procos S.p.A.
Record Details
Procos S.p.A., an Active Pharmaceutical Ingredient manufacturer in Cameri, Italy, was cited for significant deficiencies during an FDA inspection. Observations included a lack of formal validation for water used in manufacturing and solvent recovery processes, as well as inadequate procedures for handling out-of-specification stability sample conditions. These issues highlight concerns with quality control and adherence to good manufacturing practices.
- Company
- Procos S.p.A.
- Product Type
- Drugs
- Person
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ID · 68c99ba1-b7da-4894-ae17-5782cd5c8e88