The FDA slapped Watertown, Massachusetts, drug manufacturer pSivida with a Form 483 after inspectors found that the facility lacked defined procedures to ensure drug uniformity and homogeneity.
The agency’s inspection from March 26 to April 4 revealed that the firm also lacked scientifically sound test procedures to confirm its drug products conformed to quality, identity, strength and purity attributes.
For example, it had inadequate procedures for handling out-of-specification (OOS) test results. The agency investigator noted during their review of source raw data for the assay of a drug product that the facility averaged a lot’s passing assay values and OOS assay values and released it without giving a valid reason for its acceptance.
