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FDA Warning Letter Explorer
FDA warning letter · Drugs

Nortec Quimica SA

Issued · Posted by FDA

FDA published a close-out letter on Oct 30, 2023. The passages below are from the original warning letter.

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 exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.

Passage 2

Your firm did not have system security and access control over its electronic data and software systems.

Passage 3

Failure of your quality unit to review batch production records and laboratory control records prior to distribution of an API batch.