The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often only issued after a company has been given months or years to resolve problems.
High Quality Organic Products Inc.
Reno, NV
The US Food and Drug Administration (FDA) has issued a warning letter to High Quality Organics Inc. for serious violations of the current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food regulations (CGMP & PC Rule). The letter, dated July 8, 2024, details inspections conducted from November 27 through December 7, 2023 and January 3-4, 2024 at the company’s ready-to-eat spice plant in Reno, NV. .
High Quality Organics Inc. processes and packages RTE organic herbs, spices, dried fruit and peels, and dried vegetables. The FDA inspection revealed significant deficiencies in the company’s compliance with the CGMP and PC rule, which are intended to ensure that food is produced under sanitary conditions and meets U.S. food safety standards. These violations include failure to implement a risk-based supply chain program and failure to conduct a required reanalysis of the food safety plan upon receipt of new information about potential hazards.
At the end of the inspection, FDA investigators provided the company with an FDA 483a FSVP Observations form.
Main violations:
Supply chain program:
- Inadequate Risk-Based Supply Program: High Quality Organics has not implemented a risk-based supply program for raw materials and ingredients that require control applied throughout the supply chain. The company’s program could not verify that the parameters selected and applied by third-party suppliers were sufficient to control the hazard posed by vegetative pathogens, such as Salmonella.
- Lack of documentation: The company did not have documentation verifying that untreated spices sent to third-party suppliers were handled according to a validated process that ensures the destruction of Salmonella.
The inability to re-analyze the food safety plan:
- New Hazard Information: After receiving a complaint in April 2023 regarding the positive test of ground organic parsley for the pesticide Chlorpyrifos, the company failed to conduct a reanalysis of their food safety plan to determine whether pesticides pose a hazard for which a control applied by the supply chain is required.
The full warning letter can be viewed here.
Hunan Gagazui Food Co. Ltd.
Hunan, China
The US Food and Drug Administration (FDA) has sent a warning letter to Hunan Gagazui Food Co., Ltd. for significant violations of the Emergency Permit Control Regulation and the Low Acid Canned Foods Regulation (LACF). The letter, dated February 9, 2024, details inspections conducted from November 20 to 23, 2023 at the company’s low acid canned food plant in Huarong County, Yueyang, Hunan, China.
Hunan Gagazui Food Co., Ltd. produces low-acid canned food products intended for export to the United States. The FDA inspection revealed serious deviations from mandatory requirements, including processing foods at temperatures and times different from those submitted to the FDA, inadequate temperature recording equipment, and the lack of proper documentation for processing and production information.
At the end of the inspection, FDA investigators provided the company with an FDA 483a FSVP Observations form.
Main violations:
Processing deviation:
- Non-conformity with planned process: The company processed products at times and temperatures other than planned and submitted to the FDA, without consulting the process authority.
Inadequate equipment:
- Lack of accurate temperature recording equipment: None of the company’s horizontal still water retorts were equipped with a temperature recording device, which is essential for ensuring good processing conditions.
Documentation issues:
- Incomplete processing data: The company’s data does not contain essential information such as the product, initial temperature, device temperature indication and correct processing data.
The full warning letter can be viewed here.
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