Sun Pharma is yet to publish the result of the US FDA inspection of its Halol plant, conducted between 27-30 August. But Form 483, issued by US FDA website does list out the details and as per that, the company has received 6 observations. Those in the know say that most of these observations can easily be corrected and not serious in nature and they all pertain to test procedures. These observations are unlikely to result into an import alert as had happened earlier.
The observations include non-inclusion of of scientifically sound and appropriate test procedures in the lab, no written procedures for production and process controls designed, no written procedures for the cleaning and maintenance of equipment and for procedures applicable to quality control.
The market has reacted pretty harshly to these observations as the past experiences with the FDA, especially for Sun Pharma has been nasty. Once better sense prevails the stock price is sure to recover.
Sun Pharma is alternating with Reliance Naval as the top loser on the BSE, going down almost 5.5% to Rs.640.95. Its 10% UC is at Rs.609.