# FDA 483 - Bausch & Lomb Incorporated - May 26, 2017

Source: https://www.globalkeysolutions.net/records/483/bausch-lomb-incorporated/96b666d6-5ab2-48f9-aae2-b0bf75cb29f0

> FDA 483 for Bausch & Lomb Incorporated on May 26, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2017-05-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspection of Bausch & Lomb, Inc. in Tampa, FL, revealed significant deficiencies across multiple systems, including production, facilities, quality, and laboratory controls. Key issues included the release of drug products potentially contaminated with Burkholderia cepacia, inadequate aseptic processing controls, and failures in complaint handling and investigations. These findings indicate a systemic lack of adherence to cGMP requirements, posing potential risks to drug product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2012-10-02](https://www.globalkeysolutions.net/records/warning_letter/bausch-lomb-incorporated/9c41ce51-d399-4c08-ac79-66b54ee5727a)
- [483 - 2016-02-25](https://www.globalkeysolutions.net/records/483/bausch-lomb-incorporated/45cce76a-463f-4655-81fb-507fb05a3d8c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ruo-h-xu/cd7df486-187e-41a2-b424-434fa8b80648)
- [Wendy G. Tan](https://www.globalkeysolutions.net/people/wendy-g-tan/aad9c7d5-1a63-43b6-bc25-531b7f4475a9)
- [Ileana Barreto-Petit](https://www.globalkeysolutions.net/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)
- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-incorporated/be8adcb1-2ff8-4ee1-b354-75428f7b75a6

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6