Indian drugmaker failed to notify FDA multiple times about issues with its sterile injectables: letter

Vials with Syringe
Shilpa failed to notify the FDA on eight occasions about consumer complaints for its sterile injectables. (Thermo Fisher)(Thermo Fisher Scientific)

Consumer complaints are a serious issues for drugmakers, particularly for those making sterile injectables. When a complaint does come in, companies are supposed to notify the FDA right away. But what happens when a drugmaker doesn't do that—repeatedly?

Despite admitting that equipment at its Telanga, India, plant was faulty and could have produced improperly sealed injectable drugs, Shilpa Medicare Limited released batches onto the market and didn't properly warn the FDA, investigators wrote in a warning letter posted online this week.

Shilpa failed to adequately address an October 2019 complaint that one batch was improperly sealed, the FDA said. In its logbooks, which the agency reviewed during an inspection in February, Shilpa tied the errors to a "breakdown of the sealing machine" that could have allowed drugs with faulty seals onto the market. Despite that, Shilpa chose to sell the batches and didn't notify the FDA within three days of receiving the complaint.

After FDA slapped Shilpa with a Form 483 in March, the company responded that it would investigate its equipment to prevent further breakdowns, but the FDA wasn't having it.

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"You provide no justification for having released the batch ... including the portion filled during the first hour of sealing, when a machine breakdown occurred," investigators wrote. "In addition, your investigation is silent regarding the vials filled prior to noting the equipment breakdown."

Shilpa also received numerous consumer reports of foreign particles in its drugs but blamed end-user error, the FDA said, without justification. In all, Shilpa received eight consumer complaints about its drugs and didn't flag the FDA on any of them; the company concluded they didn't meet the standard for a field alert report (FAR).

The FDA disagreed. "We are concerned with the CGMP violations demonstrated at your facility and failure to submit FAR-related events within three days of becoming aware of a problem," investigators wrote.

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But the issues weren't just tied to consumer complaints; Shilpa also didn't properly handle its own internal testing that turned up problems with its drugs.

During a test in June 2019, Shilpa workers found impurities in a sample of one of its sterile injectable products, the FDA wrote. The drugmaker re-ran the test and found similar results without identifying a root cause.

Still, the FDA said, Shilpa later tied the questionable results to contamination but offered no documentation to support that conclusion and "made no meaningful effort to determine if the sample was contaminated."

In follow-up investigations, samples repeatedly failed tests, but then passed after employees washed a load column on the fill line with water, the FDA said.

Shilpa also found other samples that were out-of-spec and tied those failures to analytical errors without justification, according to agency investigators.