Mr. Boligala C. Raju
Chief Executive Officer
High Quality Organics, Inc.
12101 Moya Blvd.
Reno , NV 89506-2600
United StatesFEI 3008497552Issued Jul 8, 2024Division of Human and Animal Food Operations West V
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008497552.
Violations2
Issue DateJul 8, 2024
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
High Quality Organics, Inc.
Location
Mr. Boligala C. Raju
Chief Executive Officer
High Quality Organics, Inc.
12101 Moya Blvd.
Reno , NV 89506-2600
United States
FEI Number
3008497552
Country
United States
Issue Date
July 08, 2024
Issuing Office
Division of Human and Animal Food Operations West V
Product Type
Food & Beverages
Status
Open
Summary
High Quality Organics, Inc. was warned for manufacturing ready-to-eat organic herbs, spices, dried fruits, peels, and dried vegetables under insanitary conditions that could result in contamination with filth or injury to health. FDA inspectors identified serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117 during inspections conducted between November 2023 and January 2024 at the company's Reno, Nevada facility. The violations included failure to comply with preventive controls provisions required for covered food facilities. The company had submitted a response detailing corrective actions on January 25, 2024, but the FDA determined the violations were serious enough to warrant formal warning letter action.
High Quality Organics, Inc. FDA Warning Letter, July 8, 2024