# FDA WARNING_LETTER - Chaotic Labz - November 17, 2014

Source: https://www.keypedia.com/records/warning_letter/chaotic-labz/4afce3ac-4bf0-4680-a519-0c1686931df2

> FDA WARNING_LETTER for Chaotic Labz on November 17, 2014. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Chaotic Labz
- Inspection Date: 2014-11-17
- Product Type: Food
- Office Name: Dallas District Office
- Summary: On November 14-17, 2014, the FDA inspected Chaotic Labz, Inc.'s facility, revealing significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated. As a distributor responsible for packaging, labeling, holding, and distributing dietary supplements, Chaotic Labz is ultimately accountable for ensuring CGMP compliance.

Key violations include:
*   Failure to implement a system of production and process controls for packaging, labeling, and holding operations (21 CFR 111.55).
*   Failure to establish specifications for dietary supplement labels and packaging (21 CFR 111.70(d), (g)).
*   Absence of written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)).
*   Failure to establish and follow written procedures for quality control operations (21 CFR 111.103, 111.65).
*   Failure to visually examine supplier invoices/certifications for received products (21 CFR 111.165(b)), exemplified by the "Mayhem" recall for undeclared drug ingredients.
*   Lack of written procedures for packaging and labeling (21 CFR 111.403), receiving products (21 CFR

## Related Officers

- [Phillip Fruechting](https://www.keypedia.com/people/phillip-fruechting/3fd08abf-f04d-4c7b-a872-1a908421f14a)
- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)
- [John W. Diehl, M.S.Program Division](https://www.keypedia.com/people/john-w-diehl/83ce50c4-b3cb-42ca-96eb-0c988068e08f)

Company: https://www.keypedia.com/companies/chaotic-labz/a0d1c124-5857-467e-9403-1fbae8f4e591

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9