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# Glenmark Pharma Hit With 483 After India Inspection
- URL: https://www.fdaweb.com/glenmark-pharma-hit-with-483-after-india-inspection/
- Published: 2025-03-10T12:00:00.000Z
- Updated: 2026-09-14T14:54:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158792

It appears that FDA has belatedly inspected India’s Glenmark Pharmaceuticals after a recent *ProPublica* investigative report found that the agency hadn’t shifted any attention to the firm’s Madhya Pradesh facility despite several recalls for pills that don’t dissolve properly. The [report](https://www.propublica.org/article/glenmark-pharmaceuticals-recalls-fda-oversight?ref=fdaweb.com) focused on a 5/2024 recall of potassium chloride extended-release tablets, and noted that the Mumbai-based firm had four recalls in the previous eight months and would have two more in the following months, all for the same issue of pills failing to dissolve properly.

“They should have been camping out there,” former FDA inspector **Patrick Stone** told the news outlet. Since the May recall, *ProPublica* said, Glenmark told FDA it had received reports of three deaths, three hospitalizations, and four other serious problems in patients who took recalled potassium chloride capsules. It’s unclear if the drug was the cause of the adverse events, it noted.

A two-week inspection last month resulted in a just-posted five-item [Form FDA-483](https://www.fda.gov/media/185699/download?ref=fdaweb.com) that cited significant GMP violations. For example, agency investigators said equipment and utensils were not cleaned at appropriate intervals to prevent contamination, and the facility failed to thoroughly review any unexplained discrepancy and failure of a batch to meet its specifications. The findings will likely be examined by agency compliance officials before deciding whether they warrant a Warning Letter.

“FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories,” the *Propublica* report says. “The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills, and never mentioned that millions of them had been sold to consumers. From the day of the first recall in 10/2023 through the next 12 months, FDA oversaw 22 recalls for drugs that didn’t dissolve correctly and could cause harm, agency data show.”

Stone said that the agency “is always late to respond. This should have been dealt with immediately.” FDA didn’t explain to *ProPublica* why Glenmark’s multiple recalls didn’t lead to a risk-based inspection. A spokesperson for FDA declined to answer questions about the Glenmark recalls or inspection history, saying the agency could not publicly discuss potential or ongoing compliance matters, the news service said.