Company: Tri-State Analytical Laboratory LLC
Product: Analyzed drug products
Date: 10/22/03
Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab autoclave procedures have not been validated adequately. [21 CFR 211.160(b)]
FDA District: New Orleans District Office
