The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.

[1srelluc]

The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.

The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant accounted for an outsized share of U.S. recalls for pills that didn’t dissolve properly and could harm people.

www.propublica.org

The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant accounted for an outsized share of U.S. recalls for pills that didn’t dissolve properly and could harm people.​

TLRD:

• Glenmark Pharmaceuticals failed to find or resolve any problems.
• FDA report says Glenmark's quality processes are so bad they can't identify the problems.

Among the string of recalls, the FDA had determined last year that more than 50 million potassium chloride extended-release capsules had the potential to kill U.S. patients.

In a report detailing their findings, the inspectors wrote that Glenmark failed to resolve why some medicines weren't dissolving properly, and they raised concerns about the factory's manufacturing processes.

FDA report - with most details redacted - is below.
- OBSERVATION 1 Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- OBSERVATION 2 -redacted

- OBSERVATION 3 There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of is specifications whether or not the batch has been already distributed.

- OBSERVATION 4 The accuracy. sensitivity, specificity and reproducibility of test methods have not been established and documented.

- OBSERVATION 5 The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality of drug products.
Sure, a few corners get cut. How else do you expect the pharmaceuticals industry to keep prices so "low"?
I'm sure they washed everything down with canal water.....Thats a sterile as it gets in India.

India produces over 40% of the generic pharmaceuticals in the USA. About 20% of general medications worldwide.