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 certain details from the public version of the letters.
Delori Industrial Co. Ltd.
Ningbo Zhejiang, China
An acidified food firm in China is on notice from the FDA for not having supervisors who have attended an approved school for instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification.
In a March 10 warning letter the FDA described an Oct. 28 through Oct. 30, 2019, inspection at Delori Industrial Co. Ltd.’s acidified food firm. During the inspection, FDA investigators found serious violations of the Emergency Permit Control regulation and the Acidified Foods regulation.
The FDA’s inspection resulted in issuance of an FDA Form 483. The firm sent a response to the FDA on Nov. 20, 2019, which included descriptions of partial corrections taken by the firm and planned timeframes for remaining corrections. The FDA sent a response on Jan. 22, 2020, but the firm was closed until February 2020, and requested additional time to respond. On Feb. 19, 2020, the FDA received the firm’s response and the FDA sent follow up questions. On March 6, 2020, the firm replied again but the FDA found the firm’s response had not addressed all the violations related to their acidified food products.
The significant violations are listed by the FDA as follows:
- The firm failed to process each acidified food in conformity with at least the scheduled process. The firm’s filed scheduled processes for their dairy beverages in (redacted) ml bottles identifies a finished equilibrium pH of (redacted) and a minimal thermal processing method of (redacted) degrees C for (redacted) minutes. However, the firm did not ensure their product was processed within the limits specified in the scheduled process. Specifically,
- The firm does not monitor the actual time their product is processed at the scheduled process temperature of (redacted) degrees C. They monitor the time the (redacted) bottle enters and exits the (redacted) pasteurizer. Their pasteurizer contains (redacted) zones, each set to different temperatures. They estimate that when the product is in the (redacted) pasteurizer for (redacted) total minutes it is in the (redacted) zones above (redacted) degrees C for approximately (redacted) minutes, the minimum process time for their acidified dairy beverage products. However, due to lack of supporting records they were unable to demonstrate or verify the minimum process time of (redacted) minutes at (redacted) degrees C was met when product dwell time in the (redacted) pasteurizer was (redacted) minutes.
- During FDA inspection, investigators observed that they did not consistently monitor the time of product entering or exiting the pasteurizer, as the processing times were either missing or incomplete for (redacted) of (redacted) batch records for product primarily intended for shipment to the US. In their response to the FDA-483, they provided measurements for the zones in their pasteurizer, to support their estimated process time; however, these measurements conflict with those taken during the inspection by their production manager and FDA investigator. Based on the measurements taken during the inspection, a dwell time of (redacted) minutes would provide a process time at (redacted) degrees C less than their minimum scheduled process. The firm must have actual time and temperature recordings for their thermal process.
- The firm’s operators are not under the supervision of a person who has attended a school approved by the commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction. Specifically, they told (redacted). This lack of training was evidenced by their inability to identify to their investigator their scheduled processes for the products they ship to the US. Further, FDA review of their thermal process monitoring records, which had been reviewed by their quality control and production managers, showed that their employees recorded process times that did not correlate with actual times written, were missing entirely, or did not meet their minimum requirement of (redacted) minutes. These records indicate their employees lack adequate training and supervision on monitoring of critical factors for their acidified processes.
In their emailed response to the FDA 483 the firm stated that someone at their firm will attend the FDA Better Process Control School in China. If they have completed a course or otherwise implemented this correction, the FDA says they must submit documentation demonstrating successful completion with their response to this warning letter.
The full warning letter can be viewed here.
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