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

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