Regulatory Guidance

FDA warns Torrent for water system laced with bacteria

Nov 20, 2019

The FDA has slapped India-based Torrent Pharmaceuticals with a warning letter for its water system at a Pennsylvania facility.

Earlier this year, Torrent was forced to recall multiple OTC drugs that the FDA said contained a bacteria that could put patients at risk of contracting an infection. Now, following an inspection of the company’s Levittown, Pennsylvania plant, the agency has pinpointed its water system as the source of the bacteria.

According to a warning letter given to the company, the plant’s water system contained many sanitary design deficiencies including “multiple dead legs and threaded pipe connections.” The agency pointed out that Torrent used this water system to produce several drug products including nasal sprays, rectal suppositories and oral solutions. 

Although Torrent had replaced the system with a temporary one, the FDA said the company had not provided sufficient evidence that the new system meets quality standards, and that its testing methods were “inadequate to reliably detect the presence of B. cepacia.”

The FDA also warned the company for manufacturing two misbranded and unapproved new drugs.

Read the full FDA warning letter.

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