# FDA 483 - Instituto Pedro Nunes - June 25, 2025

Source: https://www.keypedia.com/records/483/instituto-pedro-nunes/87099a20-6bc1-4ed9-b3f5-175c1a04e708

> FDA 483 for Instituto Pedro Nunes on June 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Instituto Pedro Nunes
- Inspection Date: 2025-06-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection conducted on June 25, 2025, at Instituto Pedro Nunes - Associacao para a Inovacao e Desenvolvimento em Ciencia e Tecnologia, identified significant deficiencies related to data integrity and quality system procedures. The observations, documented on an FDA Form 483, highlighted a lack of appropriate controls over computerized systems used for analytical testing of active pharmaceutical ingredients (APIs) and drug products.
Specifically, the firm's Malvern Mastersizer and Netzsch DSC 204 F1 Phoenix systems, utilized for particle size distribution and differential scanning calorimetry respectively, lacked adequate controls to prevent unauthorized modification or deletion of electronic data. While deleted files were archived, there was no procedure for reviewing this archived data. Furthermore, these systems lacked comprehensive audit trails to document user actions, including who deleted data, when, and why, compromising the trustworthiness of analytical results.
Additionally, the inspection found that the responsibilities and procedures for the quality control unit were not adequately documented in writing. There was no established procedure for routinely reviewing audit trails generated by computerized systems like the Rigaku SmartLab (x-ray diffraction) and Netzsch DSC 204 F1 Phoenix, despite these systems having audit trail capabilities. This indicates a systemic failure in ensuring the integrity of critical testing data.
To address these observations, Instituto Pedro Nunes must implement robust data governance policies, establish comprehensive electronic record controls, and develop written procedures for audit trail review and data management. These corrective actions are essential to ensure the reliability and integrity of their analytical data, aligning with regulatory expectations for pharmaceutical manufacturing.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/instituto-pedro-nunes/e5c4f3a3-6b59-4ec9-8b5b-a657fd4ebd20

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8