FDA warning letter smacks Indian lab for repeated shortcomings

The FDA has issued warning letters blasting any number of Indian API and drugmakers for not carefully testing drugs or sometimes fabricating test results of batches of their products that they shipped to the U.S. Now the agency has sent a warning letter to an Indian contractor some companies rely on for product testing and analysis, noting repeat violations of GMP standards.

The letter, issued July 23 and posted by the FDA Wednesday, is for Sipra Labs in Hyderabad. And while the company is not a manufacturer, the agency says, it "considers contractors as extensions of the manufacturer's own facility." It said the lab's "failure to comply with CGMP may affect the quality, safety, and efficacy of the products you test for your clients."

The letter ties back to an inspection done at the company's facility in February and March of 2014, which resulted in a Form 483 with 9 observations. The company has posted that document on its company website. According to it and the letter, FDA inspectors raised concerns with a number of its documentation techniques it provided for the validation of elemental impurities of rhodium in antibiotics doxocycline and doxocycline hyalite.

Among problems noted this time, and in past inspections, has been the fact that many of its methods to test products have not been verified or validated. In fact, the agency said that only four of the 14 analytical methods identified in a 2011 inspection have since been validated. It also said that Sipra labs was not only failing to thoroughly investigate anomalies, unexpected events, or out-of-trend results but was not letting clients know about them.

The FDA has issued a string of warning letters against Indian drugmakers for drug testing and analytics problems. Last month it sent one to Mahendra Chemicals in Gujarat, after investigators found a record-keeping mess that raised questions about the quality of the active pharmaceutical ingredients (APIs) that it shipped for use in U.S. drugs. It noted forged signatures of directors who were not in the plant were found on some records, and some signatures backdated to indicate they approved drugs before they were shipped, when in fact, they hadn't.

- here's the warning letter

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