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# Bayer Chloroquine Donation Questioned
- URL: https://www.fdaweb.com/bayer-chloroquine-donation-questioned/
- Published: 2020-04-16T12:00:00.000Z
- Updated: 2026-09-14T16:11:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146588

Bayer’s donation of three million Resochin (chloroquine phosphate) tablets to the U.S. national stockpile for use in treating Covid-19 patients is raising red flags, according to a Reuters article. The news service [says](https://www.reuters.com/article/us-health-coronavirus-bayer-chloroquine/exclusive-bayers-chloroquine-donation-to-u-s-raises-concern-about-fda-standards-in-pandemic-idUSKBN21Y2LO?ref=fdaweb.com) three U.S. government sources familiar with the donation told it there is reason to be concerned about the quality of Resochin and its makers in India and Pakistan.

The sources indicated that the plants that make Resochin finished doses and ingredients in India and Pakistan have never been registered with or inspected by FDA. And while some chloroquine drugs were already approved by FDA as antimalarial medications, Resochin had not been approved.

The news service reports that Pakistani regulators that inspected Bayer’s Resochin plant in Karachi in 2015 found a “gross failure” in manufacturing processes there. And although FDA has not inspected the Indore, India, plant that supplies Resochin ingredients, it has inspected other Indian plants run by the same supplier and found serious deficiencies, including falsification of records.

An agency spokesperson told Reuters that FDA “sampled and tested the donated drugs to evaluate acceptability for importation” and they met appropriate standards. The three government sources who spoke to Reuters and an independent expert all said that spot-testing is not always sufficient to ensure a drug’s safety and effectiveness and plant inspections are crucial to ensuring overall quality.

“If you’re talking about millions of doses, you can’t test every product,” said **Stephen Payne**, who is reported to have spent years chairing a global law firm practice group specializing in FDA and health care. “You have no idea what you don’t know.”