Warning Letter Cites Repackaging Company Safecor for Mixing Up Drugs
A mix up that put a vitamin in a blister pack where a drug to prevent organ transplant rejection belonged is one of several violations the FDA cited in its warning letter to Safecor, a Columbus, Ohio, drug manufacturer and repackaging company.
During its March 7-16 inspection, investigators also found that an 80 mg blood clot prevention drug, enoxaparin, had been labeled as 30 mg and observed “a variety of different capsules and tablets on and under” the blister packing machine “while packaging a lot of 81 mg chewable aspirin tablets.”
Safecor also didn’t test incoming components such as water used to manufacture prescription drug products and told the FDA investigators that the company purchases water for pharmaceutical use “and only performs a visual inspection of the water, no other tests are performed.”
The FDA gave the company 15 days to write “what you have done to address any violations and to prevent their recurrence.”
Read the warning letter here.
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