CGMP Violations
The firm failed to test the drug product, for the identity and strength of each active ingredient prior to release for distribution.
The firm lacked approved specifications for the product. The Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use.
As the firm lacked adequate testing of each batch of the drug product, firm does not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.
The firm failed to test the active pharmaceutical ingredients (API) and other components, prior to use in the manufacture of the drug product.
The firm also lacked approved specifications to assure API and other components conform with appropriate specifications for identity, strength, quality, and purity. Though the firm receives raw materials with a certificate of analysis from the suppliers, firm have not performed an appropriate incoming analysis of component lots upon receipt, including confirming the identity prior to use in the production of the finished drug product.
The firm also relied on the supplier's certificate of analysis without establishing the reliability of your component supplier's test analyses at appropriate intervals.
Check whether these gaps are there on your site?
If no then its in compliance & if no then what actions are you going to take now?