1Deviation, CAPA, and investigation
The quality control unit lacks authority to investigate critical deviations of approved procedures.
Inspection Record
Immunomedics, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Retesting procedure for the is inadequate.
3Deviation, CAPA, and investigation
Deviation initiation and closing times are inadequate.
4Material and supplier control
The tay, material sampling and testing nrogram is inadequate, Specifically: a.
5Data integrity
There is no assurance that samples and batch records from the process validation and commercial batches manufactured prior to February 2018 were not impacted by the data integrity breach.
6Equipment and facility
Differential pressure between GMP areas of different area classification is not adequately maintained and monitored.
7Contamination control
The procedure to prevent contamination of the mend after is inadequate for a product stored 2 to 8°C for up to Specifically, during a mock and dispensing ofan surrogate conducted on August 9, 2018, the following was observed: a.
8Data integrity
The firm lacks procedures for inventory audit trail and for tracking and reconciliation ofraw materials used to manufacture the Specifically: a.
9Other quality system
There is no signed Quality Agreement between and Immunomedics Inc.
10Equipment and facility
The design ofthe facility is inadequate in that no drains are present in the rooms.
About this record
Extracted automatically from the document US FDA published on 2019-02-12. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
