# FDA 483 - Procter & Gamble Manufactura S. de R.L. de C.V. - June 27, 2025

Source: https://www.keypedia.com/records/483/procter-gamble-manufactura-s-de-rl-de-cv/71e6f255-8d50-446f-9c48-ff9df5e8a582

> FDA 483 for Procter & Gamble Manufactura S. de R.L. de C.V. on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Procter & Gamble Manufactura S. de R.L. de C.V.
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Procter & Gamble Manufactura S. de R.L. de C.V. in Naucapan, Mexico, an OTC human drug manufacturer, revealed significant deficiencies. The firm failed to thoroughly investigate an empty bottle customer complaint due to inadequate check weigher validation. Additionally, batch production records were deficient, lacking proper data integrity controls and identification of personnel supervising critical steps in electronic spreadsheets used for weight verification.

## Related Documents

- [WARNING_LETTER - 2023-03-21](https://www.keypedia.com/records/warning_letter/procter-gamble-manufactura-s-de-rl-de-cv/e6fb5156-1f3e-42c6-b159-f870c34b5b79)

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/procter-gamble-manufactura-s-de-rl-de-cv/8b78eeab-6efe-4a8d-b98a-c1bfda966646

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3