# FDA 483 - CHEMATICS, INC. - March 12, 2020

Source: https://www.globalkeysolutions.net/records/483/chematics-inc/ba980d35-9c38-4288-8a5d-22a216fe8ab6

> FDA 483 for CHEMATICS, INC. on March 12, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CHEMATICS, INC.
- Inspection Date: 2020-03-12
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of CHEMATICS, INC. in Leesburg, IN, revealed significant deficiencies in their manufacturing processes, particularly concerning the Alco-Screen 02 packaging. The firm failed to adequately validate critical process parameters, control validated process parameters, and establish proper corrective and preventive actions for product complaints, including a repeat observation. These issues indicate a lack of robust quality system controls.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/chematics-inc/b4d4bc57-836e-4883-9c3a-43b3d72f8edf

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0