As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Desert Premium Group LLC
Greenwood Village, CO
A food firm in Colorado is on notice from the FDA for violations of Emergency Permit Control and Acidified Foods regulations at a New Mexico facility.
In a Dec. 2 warning letter, the FDA described a Sept. 22-28, 2020, inspection at the Desert Premium Group LLC acidified food manufacturing facility.
The FDA’s inspection revealed that the firm was not in compliance with Emergency Permit Control and Acidified Foods regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
- The firm’s acidified food products are not manufactured in accordance with the scheduled process. Specifically, FDA inspection revealed that they failed to file the updated scheduled processes with FDA that they are currently using to monitor critical parameters for their products, including but not limited to, Hatch Valley Flame Roasted Green Chile packaged in 72 oz. plastic jugs and Hatch Valley Salsa in 12 oz. glass jars as follows.
- The firm is manufacturing Hatch Valley Flame Roasted Green Chile product, packaged in a 72 oz. plastic jug, under a scheduled process filed with the Submission Identifier (SID) (redacted). This scheduled process was filed with the FDA on 02/08/2016. The critical factors identified in this filing include a cook temperature of (redacted)°F for (redacted), a minimum fill temperature of (redacted)°F, a (redacted) and an equilibrium pH of (redacted) or below. However, the critical parameters they are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. The current parameters they are using in producing this product are from the 2019 process authority letter and require a cook temperature of (redacted)°F for a minimum of (redacted), a fill temperature of no less than (redacted)°F, and an (redacted) time of no less than (redacted). They have not filed the critical parameters provided in their current process authority letter with FDA.
- The firm is contract manufacturing Trader Joe’s brand Hatch Valley Salsa product in 12 oz. glass jars under a scheduled process filed with the Submission Identifier (SID) (redacted). This scheduled process was filed with the FDA on 11/20/2017 under the name Trader Joe’s Hatch Valley Salsa. The critical factors identified in this 2017 filing include a cook temperature of (redacted)°F for (redacted), a minimum fill temperature of (redacted)°F, use of a (redacted) instead of (redacted) to sterilize the lid, and an equilibrium pH of (redacted) or below. However, the critical parameters they are currently following in producing the same Hatch Valley Salsa product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 letter (referring the product as “Trader Jose’s Hatch Valley Salsa) require a cook temperature of (redacted)°F for (redacted), a hot fill at no less than (redacted)°F, an (redacted) of the filled jars for a minimum of (redacted), and an equilibrium pH of (redacted).
The firm, under the names Treasure Valley Specialty Foods and Flagship Foods, was previously cited for failing to file scheduled processes or failing to follow scheduled processes in inspections conducted 4/8-11/2014, 5/3-13/2016, and 10/23-26/2017. This appears to be a systemic issue in the firm’s operations. They promised to correct this deficiency at the closing of each of the aforementioned inspections; however, each inspection conducted that evaluated the controls in their acidified food operations found they have failed to manufacture products according to the current filed process and have not filed the process they are using in production.
- The firm failed to handle process deviations involving acidified Salsa and Green Chile sauce. Specifically:
- The firm contract manufactured Hatch Valley Salsa in 12 oz. glass jars on 04/06/2020 under Lot D040620. On 04/08/2020, the equilibrium pH was determined to be (redacted) from product that was prepared as Batch (redacted) and filled on 04/05/2020 during (redacted). The firm’s current process authority letter for this product dated 12/20/2019 requires an equilibrium pH of (redacted) or below and their filed scheduled process requires an equilibrium pH of (redacted) or below when measured no less than (redacted) after production. Lot D040620, Hatch Valley Salsa was released for distribution into commerce without their firm evaluating this process deviation or following any of the options required under 21 CFR 114.89
- The firm manufactured Hatch Valley Flame Roasted Green Chile in 16 oz. glass jars, Lot D060820, on 06/08/2020. Their current process authority letter dated 12/20/2019 requires a minimum cook time of (redacted). The cook start time for Hatch Valley Flame Roasted Green Chile, Lot D060820, Batch (redacted), was recorded as (redacted) and the cook end time was recorded as (redacted). This is a total cook time of (redacted). Lot D060820, Hatch Valley Flame Roasted Green Chile, was released for distribution into commerce without this process deviation being evaluated or the firm taking any of the steps required under 21 CFR 114.89.
Additionally, when these deviations occurred their acidified foods were not being produced under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.
The full warning letter can be viewed here.
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