# FDA 483 - PROSANA DISTRIBUCIONES SA DE CV - March 09, 2017

Source: https://www.keypedia.com/records/483/prosana-distribuciones-sa-de-cv/eee5a0ec-78ab-4936-9f0c-29242ab334d3

> FDA 483 for PROSANA DISTRIBUCIONES SA DE CV on March 09, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PROSANA DISTRIBUCIONES SA DE CV
- Inspection Date: 2017-03-09
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of PROSANA DISTRIBUCIONES SA DE CV, an OTC drug manufacturer in Mexico, revealed significant deficiencies in its quality system. The firm lacked essential written procedures, process validation, and quality control oversight for its Bicaruvas Antiacid Efervescent Powder, raising concerns about product identity, strength, quality, and purity. Key issues included inadequate batch records, raw material controls, equipment cleaning procedures, yield calculations, labeling controls, stability data, and employee training.

## Related Documents

- [WARNING_LETTER - 2017-03-09](https://www.keypedia.com/records/warning_letter/prosana-distribuciones-sa-de-cv/0ba39209-cc40-423d-87bc-b87aa4ac050f)

## Related Officers

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/prosana-distribuciones-sa-de-cv/8e88ee9d-28d4-460a-85f0-539fa42eeaa0

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321