Since there are many opportunities for things to go wrong, you employees are doing their best. When you see what they are doing correct, call that out. If you see any areas of opportunity on the items listed above, use them as a coaching and leaning opportunity and share it with your facility and company.
Our goal is to manufacture products properly, build a safe food supply, secure jobs for our workforce, and eliminate waste, so we can feed more people, animals, and take care of one another with our medicines and products we sell.
FDA Recalls
Period: October 10, 2021 – October 16, 2021 there were three (3) FDA recalls reported.
- Animal and Veterinary, Pet Food for an elevated level of Vitamin D
- Drug – One for Super Potent and one for API batches above the specification limit for the impurity, N-nitrosoirbesartan.
USDA Recalls
Period: October 10, 2021 – October 16, 2021, there was one (1) USDA recall reported as a High Class 1 Recall due to Product Contamination.
While the details of all 4 recalls are not available (3 FDA Recalls and 1 USDA Recall), there are some areas you can look at within your operation to see if you have any opportunities for improvement and to prevent a recall in your facility or company.
- Review how vitamins or specific ingredients are weighed or added to your products. If the addition uses a pump, how is the pump monitored, calibrated, or maintained?
- Review your batching process and batching records.
- Review your training programs for laboratory, sanitation, and processing / operations employees.
- Review your incoming receiving, inspection, retained sampling, and use of ingredients.
- Review your process on how ingredients are packaged and if there is an opportunity for these to enter your production stream.
- Review your finished product sampling and testing procedures.
- Review your release (and positive release programs)
- Review your “Product Hold” areas and how products are held to prevent shipment.
- Review your communication and escalation procedures.
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