IGMPI India

Natco Pharma and Orchid Chemicals and Pharmaceuticals have received an adverse observation report, known as Form 483, after inspections conducted in their manufacturing units earlier this year by the US Food and Drug Administration. The letter was issued after the regulatory body found deviations from the standard quality control practices.

The US FDA inspected Natco Pharma's dosage facility located in Mahabubnagar district in Telangana in May. The regulator made six observations, all of which pertain to quality control standards. The company did not have any written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or represented to possess. It further mentioned that the company's quality control unit lacked responsibility to approve or reject procedures that impact quality and purity of drugs.

The USFDA inspected Orchid's manufacturing unit located in Waluj in Maharashtra in April 2014. The regulator issued seven observations in its report where they raised issues with the company's quality system. The inspection report stated that test procedures were not scientifically sound and appropriate to ensure that raw materials, intermediates and active pharmaceutical ingredients (APIs) conform to established standards of quality and purity. Also, equipment cleaning/sanitation study did not address microbiological and endotoxin contamination for those processes where there was a need to reduce total microbiological count or endotoxins in the API, or other processes where such contamination could be of concern.