FDA WARNING_LETTER - TREEHOUSE FOODS, INC - September 24, 2021

The FDA inspected a low-acid canned food (LACF) facility in Cambridge, Maryland, from September 21-24, 2021, and found serious deviations from 21 C.F.R. Part 108 (Emergency Permit Control) and 21 C.F.R. Part 113 (Thermally Processed Low-Acid Foods). The facility has been under Emergency Permit Control since October 27, 2011.

Key violations include: 1. **Failure to conduct and record regular observations of closures and take corrective actions (21 C.F.R. 113.60(a)):** The filler operator's visual seam inspections were inadequate ("quick look"), and no corrective actions were documented for observed defects like loose/fractured seams on multiple production days. Additionally, the firm used damaged incoming cans, with up to 8.6% rejection, and did not review electronic container integrity records. The firm's response, including updated procedures and training, was deemed inadequate due to a lack of completed records. 2. **Inadequate teardown examinations for double-seam cans (21 C.F.R. 113.60(a)(1)):** The operator did not measure two different locations during teardown examinations, and tightness (wrinkle) was measured without physically removing the seam. Can specifications for