# FDA 483 - Organics Corporation of America DBA Ambix Laboratories - February 24, 2014

Source: https://www.keypedia.com/records/483/organics-corporation-of-america-dba-ambix-laboratories/04c12c5d-09e3-4e70-904c-40f66a2c0d1a

> FDA 483 for Organics Corporation of America DBA Ambix Laboratories on February 24, 2014. Product: drugs. 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: 2014-02-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Organics Corporation of America DBA Anabolic Laboratories in Totowa, NJ, revealed significant deficiencies in their manufacturing processes for dietary supplements. Observations included incomplete batch production records that failed to document the actual weights of components used. Additionally, balances used for weighing ingredients were not properly calibrated or checked for operation within their actual range of use, indicating a lack of adequate quality control.

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## Related Officers

- [Eric Rothschild](https://www.keypedia.com/people/eric-rothschild/74d4ca43-8e3a-47f2-875c-053f1a613ce4)
- [Melissa B. Libby](https://www.keypedia.com/people/melissa-b-libby/844cdff5-c7e5-4733-a5f4-e1eea8587ced)
- [Charles J. Chacko](https://www.keypedia.com/people/charles-j-chacko/91b779f7-62f5-455e-89b1-f1da3800bffd)

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