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# CGMP Deviations at Brazil’s Nortec Quimica
- URL: https://www.fdaweb.com/cgmp-deviations-at-brazils-nortec-quimica/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153444

A 7/18-7/22/22 FDA inspection at the Nortec Quimica drug manufacturing facility in Rio de Janeiro, Brazil, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 12/8/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nortec-quimica-sa-639894-12082022?ref=fdaweb.com) said the specific deviations were:

- failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failing to have adequate controls to prevent omission of data; and
- failure of the firm’s quality unit to review batch production records and laboratory control records before the distribution of an API batch.

The letter says Nortec’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA says the firm should engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before Nortec pursues the resolution of its compliance status with FDA.

Nortec was told to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.