# FDA 483 - Auro PR Inc - March 15, 2018

Source: https://www.keypedia.com/records/483/auro-pr-inc/e251f642-af25-442e-aa4f-6709f8740d8b

> FDA 483 for Auro PR Inc on March 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Auro PR Inc
- Inspection Date: 2018-03-15
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Mylan LLC in Caguas, PR, a drug manufacturer, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in the visual examination of received components, the qualification and calibration of dissolution testing instruments, and the cleaning and maintenance procedures for equipment and utensils. These issues indicate a lack of adequate controls to ensure product quality and integrity.

## Related Documents

- [483 - 2023-05-31](https://www.keypedia.com/records/483/auro-pr-inc/53e7b1af-7cf1-4f49-a86c-c6f71c5d83cf)

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Jose R Flores-Veguilla](https://www.keypedia.com/people/jose-r-flores-veguilla/e048ce78-9ed3-479c-be29-31471900e258)
- [Wilmary Negron Rodriguez](https://www.keypedia.com/people/wilmary-negron-rodriguez/e7bb04eb-ed58-4e4c-932d-1069c76c0215)
- [Jose R. Lopez](https://www.keypedia.com/people/jose-r-lopez/f4e8e5fa-4765-4d8b-828d-32c202f8dadc)

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9