The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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. PepsiCo Inc. Purchase, NY The FDA has issued a warning letter to PepsiCo Inc.
about its now-closed Quaker Oats facility in Danville, IL. The letter revealed a history of positive Salmonella tests dating back to 2020, with a strain matching the one responsible for the recall of Quaker Oats products in 2023 and 2024. The Quaker Oats recall began on Dec.
15, 2023, with more than 40 products implicated. The recall was expanded on Jan. 12, 2024, with two dozen more products pulled.
The company closed its manufacturing facility in Danville, IL in June of this year. The company has shifted production of products made at the plant to other facilities. In a June 12, 2024, warning letter, the FDA described a Dec.
19, 2023, through Feb. 2, 2024, inspection of PepsiCo Inc.’s manufacturing facility in Danville, IL.
The facility manufactures ready-to-eat (RTE) granola bars and RTE cereals. During the inspection of their facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule.
