# FDA 483 - American Chinese Medicine Association, Inc - January 20, 2022

Source: https://www.keypedia.com/records/483/american-chinese-medicine-association-inc/d15b9e94-4238-43f4-b964-d717572e3a66

> FDA 483 for American Chinese Medicine Association, Inc on January 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Chinese Medicine Association, Inc
- Inspection Date: 2022-01-20
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2018-05-31](https://www.keypedia.com/records/warning_letter/american-chinese-medicine-association-inc/dbdcf9c1-c837-4b1a-92ea-62e1310acaf9)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-p-diorio/fba94f6f-38b9-4d30-b8a1-d6c9d4769e49)

Company: https://www.keypedia.com/companies/american-chinese-medicine-association-inc/389421de-e688-404d-a7ee-50b76d395e95

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669