Warning Letter: Failure to maintain computer records (ucm530565)


Ofni Systems

In addition, on April 2, 2016, “pickled sweet radish cut” was processed at a temperature range of from 35- 58°C (94 op to 136.4°F) according to computer records which is lower than the minimum temperature of [redacted] listed on your filed scheduled process…

Your firm failed to maintain required records in accordance with 21 CFR Part 114.100(e) for a period of 3 years from the date of product manufacture. Concerning our request for temperature recording data records for a lot of Burdock manufactured on 4/13/2015, your firm replied that you keep computerized records for less than a year on a computerized file…

More specifically, your request should include documentation that reflects the changes you made, such as a copy of your filed scheduled processes, five (5) consecutive days of completed monitoring records (i.e., records for the production of five (5) production date codes of the products), and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations.

 

View the original warning letter.


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