# FDA WARNING_LETTER - Garden of Flavor LLC - February 07, 2014

Source: https://www.keypedia.com/records/warning_letter/garden-of-flavor-llc/d04c6809-6dc5-44de-ad52-3bf71895953a

> FDA WARNING_LETTER for Garden of Flavor LLC on February 07, 2014. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Garden of Flavor LLC
- Inspection Date: 2014-02-07
- Product Type: Food
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Garden of Flavor, LLC's manufacturing facility from January 14-15 and February 4, 7, 2014, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render their 100% juice blends, including "Lemon Pepp" and "Mean Green," adulterated under Section 402(a)(4) of the Food Drug and Cosmetic Act.

Key violations include:
1.  Lack of evidence for a 5-log reduction of pertinent microorganisms: The firm's validation studies for their (b)(4) process were inadequate, using a "cocktail" of microorganisms instead of a pertinent one for each juice, and not addressing Brix, acidity, or shelf-life under moderate abuse conditions.
2.  HACCP plan not specific to each juice type: The firm used one HACCP plan for all juice products, failing to list hazards for each specific blend as required by 21 CFR 120.8(a)(2).
3.  Insufficient monitoring of GMPs: The firm did not adequately monitor water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from adulteration, toxic compound control, and employee health conditions. Their response lacked specified monitoring frequencies and records.
4.  Inappropriate corrective actions: The corrective action

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)

Company: https://www.keypedia.com/companies/garden-of-flavor-llc/5517fbe3-9cb0-4d32-9e56-514e37847920

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22