483
American Chinese Medicine Association, IncAmerican Chinese Medicine Association, Inc – FDA 483, Jan 20, 2022
Record Details
An FDA inspection of American Chinese Medicine Association, Inc. in Aurora, IL, a drug manufacturer, revealed six significant violations of current Good Manufacturing Practices. The firm lacked written quality control procedures, failed to perform required product testing, and did not maintain adequate stability programs or batch production records. Additionally, drug products were distributed without proper lot numbers or expiration dates on their labeling.
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ID · d15b9e94-4238-43f4-b964-d717572e3a66
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