Proquimes S A Productos Quimicos Especializados S.A.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Passage 2

Failure to adequately perform qualification of critical equipment and ancillary systems.

Passage 3

Failure to adequately validate written procedures for the cleaning and maintenance of equipment.

Passage 4

Failure to test the identity of each batch of incoming production material.