Ars Technica: Shredded documents found at cisplatin manufacturing facility in India

Via Beth Mole at Ars Technica, this alarming description of the quality problems at a single cisplatin manufacturer that precipitated the current cisplatin and carboplatin shortage: 

The current shortage was triggered late last year when the Food and Drug Administration inspected a drug manufacturing facility owned by Intas Pharmaceuticals in Ahmedabad, India. Inspectors found egregious violations. Afterward, Intas voluntarily shut down the facility, which had supplied around half of the generic cisplatin and carboplatin in the US.

The stunning inspection report, released in January, leaves no doubt as to why the plant was shut down. In addition to various manufacturing violations, including laboratory and quality control problems, inspectors reported finding a truck 150 meters from the facility loaded with plastic bags full of shredded and torn documents. When the inspector dug into the documents, they realized they were quality-control documents and analytical weight slips.

In another instance, the inspection report notes that an employee, upon learning the FDA inspectors were walking through the quality-control lab, ran to the balance room and "immediately rushed and tore apart balance printouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container located next to the balance. Later, he threw [redacted] acid solution inside the same trash in an attempt to destroy the evidence." The bag of torn, acid-soaked reports was later found stuffed under a staircase.

The FDA has since tried working with other manufacturers to boost production of the cancer drugs and is exploring temporarily importing drugs from China to ease the shortage. But many generic drug facilities already work at capacity, making a boost in production difficult to impossible. It's also unclear how much the imported drugs will help.

Pretty old hat stuff, to be honest. For some reason, this seems to be a pretty common thing to find with certain drug manufacturers. Seems to me that the hospitals and pharmacies in the US have cut the prices for these particular drugs a bit too low, and they need to raise the price to keep some decent manufacturers still in the game...