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Updated: 18 March 2019

Inspection standards of the FDA were same since last 15 years, only the audit frequency has changed. The number of FDA inspections has increased in recent years due to several reasons such as more applications for Abbreviatived New Drug Applications which demand inspection for each filing and GDUFA fee where applicants pay to FDA to get the inspection done. It has been observed that Indian companies are not improving their quality even after getting observations from FDA.

Indian pharmaceutical companies are not working on the compliance which must have been done. Whenever FDA has an observation, the company thinks that they have fewer stakes in the US. However, FDA requirements must be adhered by company whenever they are producing specific product for US market.

The big pharmaceutical manufacturers such as Aurobindo, Lupin have enhanced their compliance levels in last few years. This must be followed by all pharmaceutical companies. A lot of experienced employees along with lot of money is required to sustain the highly compliance environment.

While discussing with Amit Rajan, Prosfora Tech, he has also explained that OAI is not new, it is a warning letter having new terminology used by the FDA these days. It means no filed ANDA or DMF from that facility will be taken for review. However, it will not impact on the product supply until it gets an import alert.