A manufacturer of acidified foods was found to be in violation of the Acidified Foods regulations because they did not fully comply with registration and filing of process information and actual processes deviated from those scheduled.
The manufacturer did not have FDA filings of their scheduled processes for each acidified food in each container size; they did not follow the minimum criteria, which resulted in deviations from the scheduled processes for certain products; and there were issues with monitoring and record keeping as well.
In response to the 483, the company provided the required information for one size of one of its products, but it did not provide the information for each container size of all of its products. Additionally, while responding that it was working with its process authority to amend the processes and documents, there was no statement that processes that rendered the products safe were implemented. Thus, a warning letter was issued to notify the company of FDA’s continued concerns and provide it with an opportunity to correct them.
