# FDA 483 - Organics Corporation of America DBA Ambix Laboratories - August 22, 2014

Source: https://www.keypedia.com/records/483/organics-corporation-of-america-dba-ambix-laboratories/ce2de9df-034b-4e6d-a2e6-32218875cc75

> FDA 483 for Organics Corporation of America DBA Ambix Laboratories on August 22, 2014. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Organics Corporation of America DBA Ambix Laboratories
- Inspection Date: 2014-08-22
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Organics Corporation of America DBA Ambix Laboratories, a dietary supplements manufacturer in Totowa, NJ, revealed significant deviations. Observations included inadequate quality control operations with unreviewed laboratory test results, incomplete batch production records lacking required verifications, and manufacturing operations that posed a contamination risk.

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## Related Officers

- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/organics-corporation-of-america-dba-ambix-laboratories/4df21aa9-1d74-422a-9874-2c8529367b71

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248