# FDA WARNING_LETTER - Cerebral Health, LLC - February 18, 2011

Source: https://www.keypedia.com/records/warning_letter/cerebral-health-llc/f0be6b29-138e-4759-b687-1adaea13c795

> FDA WARNING_LETTER for Cerebral Health, LLC on February 18, 2011. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cerebral Health, LLC
- Inspection Date: 2011-02-18
- Product Type: Food
- Office Name: Florida District Office
- Summary: On May 23, 2011, the FDA issued a Warning Letter to Cerebral Health, LLC, following an inspection from February 8-18, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  Failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)).
2.  Failure to establish product specifications for finished dietary supplements (21 CFR 111.70(e)).
3.  Failure to establish identity specifications for dietary ingredient components (21 CFR 111.70(b)(1)).
4.  Failure to conduct identity testing for dietary ingredient components (21 CFR 111.75(a)(1)).
5.  Failure to establish and follow written procedures for quality control operations, including material review and disposition (21 CFR 111.103).
6.  Failure to prepare and keep batch production records (21 CFR 111.255).
7.  Failure to establish and follow written procedures to review and investigate product complaints (21 CFR 111.5

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/cerebral-health-llc/c4a70079-72d3-413a-9e56-dd66ef047a4c)

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/cerebral-health-llc/2087649e-96b5-407f-81ab-cda54518440c

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9