# FDA 483 - F. Hoffmann - La Roche Ltd. - August 05, 2022

Source: https://www.keypedia.com/records/483/f-hoffmann-la-roche-ltd/05362655-43dd-4e12-8b22-81f7713de50d

> FDA 483 for F. Hoffmann - La Roche Ltd. on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: F. Hoffmann - La Roche Ltd.
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: F. Hoffmann - La Roche Ltd. in Kaiseraugst, Switzerland, a parenteral and solid dose drug manufacturer, was cited for deficiencies during an FDA inspection. The observations include inadequate investigations into unexplained discrepancies, particularly concerning foreign particles in drug products. Additionally, the firm's aseptic processing areas showed insufficient environmental monitoring and inadequate controls over microorganisms, including issues with operator protective equipment and cleaning procedures.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/f-hoffmann-la-roche-ltd/622e8fa3-95f3-4ed9-a1bd-99dc0748f273

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1