Latest stories

​The digital escort fraud: another major Pentagon security failure 'Active nonaligment' on the march in a multipolar world

Cog war's glaring and growing legal blind spot

ProPublica reported last month that a low-profile group inside the agency at the same time exempted some medications from that ban, ostensibly to prevent drug shortages. The FDA has granted similar exemptions for drugs made at more than 20 other foreign factories that violated critical standards in drugmaking and were barred from the US market.

The FDA kept the practice largely hidden from the public. The agency did not regularly test drugs coming from the banned factories or proactively monitor reports about potential harm among consumers, ProPublica found.

In Sun's case, more than a dozen drugs were initially excluded from the Halol import ban. The company is still allowed to send five to the United States, government records show , including vecuronium bromide, a muscle relaxer used during surgery, and the cancer drug doxorubicin. Also excluded are divalproex delayed release tablets, which treat seizures and other conditions; leuprolide injection, used by people with prostate cancer, endometriosis and other conditions; and temozolomide capsules, for brain cancer.

The inspection last month marked the first time the FDA had been back to the factory in the 2.5 years since it imposed the import ban and Sun started sending exempted drugs to the United States. Inspectors found that procedures designed to prevent microbiological contamination of sterile drugs were not established or followed and that equipment wasn't maintained to prevent malfunctions that would“alter the safety, identity, strength, quality or purity of the drug product,” according to the report.

Some of the concerns focused on the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA blacked out the names of the drugs that were potentially compromised on its publicly released inspection report, including a medication made on a manufacturing line in which several batches had to be rejected because they were filled with black particles.

“It's disappointing to see issues continue to come up at this site given the site's role in potentially manufacturing critical drugs for US consumers,” said the person familiar with the inspection findings.