# FDA 483 - Auro PR Inc - May 31, 2023

Source: https://www.globalkeysolutions.net/records/483/auro-pr-inc/53e7b1af-7cf1-4f49-a86c-c6f71c5d83cf

> FDA 483 for Auro PR Inc on May 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Auro PR Inc
- Inspection Date: 2023-05-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Auro PR Inc, a drug product manufacturer in Caguas, PR, received a Form 483 with two observations following an FDA inspection from May 23-31, 2023. The inspection revealed significant deficiencies in the firm's stability program, including improper storage of stability samples and a lack of assurance that drug products are tested in their marketed container-closure systems. Additionally, the firm failed to ensure appropriate laboratory testing for objectionable microorganisms, evidenced by ineffective corrective actions and a lack of scientific rationale for changes in microbial monitoring procedures.

## Related Documents

- [483 - 2018-03-15](https://www.globalkeysolutions.net/records/483/auro-pr-inc/e251f642-af25-442e-aa4f-6709f8740d8b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.globalkeysolutions.net/companies/auro-pr-inc/131d65a0-af2e-4119-a398-8793dc5bf564

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6