Unexo Life Sciences, an Indian drugmaker that manufactures a medicated patch for pain relief, has been hit with a warning letter from the FDA.
The letter, which cites "significant" problems at the company’s facility in New Delhi, was preceded earlier this year with a Form 483 that was issued in the wake of a May inspection. The U.S. regulatory agency reviewed Unexo’s June response and said the company's proposed actions for remediation were inadequate.
In the Nov. 6 warning letter, which was recently posted to the FDA website, the agency said Unexo’s quality control unit failed on a number of fronts related to record keeping.
In one instance, a quality control analyst had “the ability to manipulate results, dates, and images" on certain records, according to the FDA.
In its original response, Unexo said the analyst in question had been removed from their regular duties. However, the FDA found that response lacking because Unexo didn’t explain in detail how it would implement data integrity controls in the future.
In another problem cited by the agency, FDA inspectors discovered that the company's primary computer for storing electronic CGMP data was not backed up and was unavailable for inspection because a quality control analyst had taken it home and could not be reached despite multiple attempts.
“When the laptop was provided all recent files and drives were apparently deleted before being presented to the investigators,” the agency said.
Additionally, FDA inspectors found the company failed to clean, maintain, sanitize and sterilize equipment and utensils at “appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product," according to the letter.
In October, the FDA held a teleconference with the company to recommend a voluntary recall of all batches of drugs sent to the U.S. The company said at the time that it would issue the recall and provide updates on efforts to initiate the recall.