FDA 483 - Organics Corporation of America DBA Ambix Laboratories - February 24, 2014
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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.
- Inspection Date
- February 24, 2014
- Product Type
- Drugs
ID · 04c12c5d-09e3-4e70-904c-40f66a2c0d1a