Sysco Regional Distribution · Manufacturing · Austin, TX · 14 weeks
FDA traceability compliance achieved in 14 weeks
A regional food manufacturer risked $3.1M in penalties for failing to meet FDA traceability rules. We developed a data governance framework that brought them into compliance within 14 weeks and cut their recall response time from 72 hours to 4 hours.
Challenge
The FDA’s FSMA rules require tracing any ingredient from farm to shelf within 24 hours. This manufacturer took 72 hours and used paper records across three facilities. An FDA inspection flagged six traceability failures and gave 90 days to fix them. The company faced potential fines of $3.1 million.
Outcome
We closed all six FDA deficiencies by week 14, beating the deadline by four weeks. We cut recall response time from 72 hours down to 4 hours. During the FDA re-inspection, no new issues came up. This prevented $3.1 million in potential fines.
Results
- $3.1M Potential penalties avoided
- 72 hrs to 4 hrs Recall response time
- 6 FDA deficiencies resolved
- 14 wks Compliance achieved
We had 90 days to fix six FDA issues or face $3.1 million in fines. Thinklytics sorted them out in 14 weeks, and we cut our recall response time from 72 hours down to 4. The re-inspection was clean.