# FDA 483 - Organics Corporation of America DBA Ambix Laboratories - May 07, 2012

Source: https://www.keypedia.com/records/483/organics-corporation-of-america-dba-ambix-laboratories/34d96b95-79ec-4298-8cbf-e984fbd158cd

> FDA 483 for Organics Corporation of America DBA Ambix Laboratories on May 07, 2012. 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: 2012-05-07
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Organics Corporation of America DBA Ambix Laboratories in Totowa, NJ, revealed significant deficiencies in the manufacturing of dietary supplements. The firm failed to verify finished product specifications, adequately test incoming components, and maintain proper cleaning and sanitizing documentation for equipment. Additionally, components were not stored under appropriate environmental conditions, indicating a lack of control over product quality and potential for adulteration.

## Related Documents

- [WARNING_LETTER - 2012-05-07](https://www.keypedia.com/records/warning_letter/organics-corporation-of-america-dba-ambix-laboratories/67b12729-944c-494a-bc78-0cf999025e91)
- [483 - 2014-02-24](https://www.keypedia.com/records/483/organics-corporation-of-america-dba-ambix-laboratories/04c12c5d-09e3-4e70-904c-40f66a2c0d1a)
- [483 - 2014-08-22](https://www.keypedia.com/records/483/organics-corporation-of-america-dba-ambix-laboratories/ce2de9df-034b-4e6d-a2e6-32218875cc75)

## Related Officers

- [Miguel G. Manzano](https://www.keypedia.com/people/miguel-g-manzano/66bb73fa-2a1c-4342-af00-7d73be19b0a9)
- [Melba T. Rivera Clavell](https://www.keypedia.com/people/melba-t-rivera-clavell/9527bc32-34f6-41d2-9c1d-24cf0ced81f8)

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