# FDA 483 - NATURA BISSE INTERNATIONAL SA - September 16, 2022

Source: https://www.keypedia.com/records/483/natura-bisse-international-sa/fbfe46de-e663-4f08-aa01-661643f8c96c

> FDA 483 for NATURA BISSE INTERNATIONAL SA on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATURA BISSE INTERNATIONAL SA
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Natura Bisse International, Inc., an OTC drug manufacturer in Cerdanyola Del Valles, Spain, received a Form 483 for deficiencies in laboratory controls and equipment design. Observations included inadequate media testing for microbial recovery and lack of growth promotion, alongside issues with equipment design, alarm management, performance qualification, and timely investigation of temperature excursions. These findings indicate a need for improved quality oversight in critical manufacturing and testing processes.

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/natura-bisse-international-sa/52b93ce0-03c9-4c21-abb2-f4307ddaedbd

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