# FDA WARNING_LETTER - Natura Bisse International S.A. - January 29, 2016

Source: https://www.keypedia.com/records/warning_letter/natura-bisse-international-sa/09a4624b-cf23-4da4-a426-a8478ad39d18

> FDA WARNING_LETTER for Natura Bisse International S.A. on January 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Natura Bisse International S.A.
- Inspection Date: 2016-01-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Natura Bisse International S.A. following an inspection from January 25-29, 2016, at their Barcelona, Spain facility, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to test drug products for identity and strength prior to release (21 CFR 211.165(a))**: Specifically, OTC drug products were not tested. This was a repeat violation from a 2013 inspection. The FDA requires a release testing program, including SOPs, retroactive assessment of in-expiry batches for the U.S. market, and copies of quality agreements with contract laboratories.
2.  **Failure to support expiration dates with appropriate stability testing (21 CFR 211.137(a))**: No stability testing program was implemented, and a 2015 recall due to product separation indicated instability. This was also a repeat violation from 2013. The FDA requires a stability testing program with stability-indicating methods, acceptance criteria, and retroactive assessment of in-expiry batches for the U.S. market.
3.  **Failure to follow required laboratory control mechanisms (21 CFR 211.160(a))**: Laboratory log sheets for microbiology, physico-chemical, and organoleptic tests lacked appropriate controls. The FDA requires

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- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/natura-bisse-international-sa/4909bb3c-be5b-4e3d-ae7d-0fb56d229963

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c