The quality control unit lacks authority to review production records to assure no errors occurred and fully investigate errors that have occurred, it further said. The FDA has already issued warning letters to two of the Wockhardt's plants in India.
The US Food and Drug Administration has found as many as 12 procedural lapses in drug maker Wockhardt 's US facility in Illinois. The inspection, which was carried out by the FDA officials between January 22 and March 26 this year, pointed out that the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
"There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or the batch has already been distributed," the report said in one of the observations.
The quality control unit lacks authority to review production records to assure no errors occurred and fully investigate errors that have occurred, it further said. The FDA has already issued warning letters to two of the Wockhardt's plants in India.
In November last year, the FDA issued an import alert, effectively a ban, against Wockhardt's Chikalthana plant in western India.
The FDA had imposed a ban on the company's Waluj plant in May.
Wockhardt's Managing Director Murtaza Khorakiwala recently told analysts that FDA had in March inspected the company's Chicago-based Morton Grove Pharmaceuticals unit, which accounts for more than 50 percent of its sales in the United States.
The building used in the manufacture, processing, packing and holding of drug products are not maintained in a clean and sanitary condition, besides the production personnel were not practicing good sanitation and health habits, the reports further observed.
When contacted a company spokesperson declined to comment. Shares of Wockhardt closed at Rs 595.15 apiece, down 3.11 percent on BSE from its previous close.
Wockhardt stock price
On June 03, 2014, Wockhardt closed at Rs 595.15, down Rs 19.1, or 3.11 percent. The 52-week high of the share was Rs 1245.75 and the 52-week low was Rs 336.60.
The company's trailing 12-month (TTM) EPS was at Rs 18.05 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 32.97. The latest book value of the company is Rs 74.39 per share. At current value, the price-to-book value of the company is 8.00.
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