# FDA WARNING_LETTER - DC Nutrition, Inc. - June 28, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/dc-nutrition-inc/aa31b094-185a-4433-80e2-1764873cf2e3

> FDA WARNING_LETTER for DC Nutrition, Inc. on June 28, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DC Nutrition, Inc.
- Inspection Date: 2012-06-28
- Product Type: Food
- Office Name: Denver District Office
- Summary: On June 26-28, 2012, the FDA inspected DC Nutrition, Inc.'s dietary supplement facility, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), causing products to be adulterated. This was a repeat observation from a previous inspection in 2011.

Violations included:
1.  **Failure to implement production and process controls (21 CFR 111.55):** No system for quality control operations, including specifications, raw material receipt/testing, or processing controls. The company's response was inadequate, lacking documentation and proposing unacceptable timelines.
2.  **Failure to establish and verify finished product specifications (21 CFR 111.70(e), 111.75(c)):** No specifications for identity, purity, strength, and composition of finished dietary supplements, nor verification testing. The response was inadequate, lacking documentation and proposing unacceptable timelines.
3.  **Deficient Master Manufacturing Records (MMR) (21 CFR 111.205(b)(1), 111.210):** MMRs lacked specifications, complete component lists, dietary ingredient identity/weight, overage amounts, theoretical yields, packaging descriptions, representative labels, written instructions, sampling procedures, and corrective action plans. The response was inadequate, lacking detail and proposing unacceptable timelines

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.globalkeysolutions.net/companies/dc-nutrition-inc/1c18bd98-a079-4e7d-975c-d63a20bda6ba

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face