For the first time in its history, Chile’s Public Health Institute has shut down a drugmaker, which had a years-long track record of quality and safety concerns, The Santiago Times reports.

BestPharma had accumulated 56 write-ups and over $7.4 million in fines between June 2006 and June 2008 for cleanliness and hygiene violations, noncompliance with operational safety measures, inconsistency of medication quality, defective packaging and mislabeling medicines and lab reagents, which are chemicals used to test other chemicals, the paper writes.

In one case cited by the paper, a piece of thread was discovered in a bottle of an intravenous antimicrobial. Epilepsy pill sheets were found with capsules missing, and the agency noted dilution consistency problems in hydrocortizone. Health inspectors claimed some products had been contaminated with human hair, glass and insects, according to the Times.

Last year, 23 BestPharma products were pulled from the market for various defects or safety concerns. In February, thousands of Fenitoína epilepsy tablets were taken off shelves, although the paper adds that, no consumer complaints were made about adverse reactions to any of the drugs.

As a result of the action, BestPharma can no longer import, distribute or commercialize its products, which it bought from different countries and sold to hospitals, clinics, doctors’ offices and pharmacies, the paper writes. The company commercialized meds for 21 years, and until 2005, was the leading provider of medicine to the public sector hospitals, the Times writes.

BestPharma must now destroy its entire inventory of inhalers, pills and intravenous drugs, though its products still remain on shelves and in doctors’ offices. The agency also fined BestPharma’s legal representative, technical director and quality control manager $35,500 each.

The closure “sends an important signal that the health of Chile’s patients is not to be played with,” agency director Ingrid Heitmann told the Times. “And we hope this is a clear signal for those who aren’t complying with (safety standards) because while we have laboratories that produce in very good quality, we also have some cases where we have problems. That’s why we will be inflexible in exercising our sanitary authority in grave situations like this.”

In 2006, BestPharma was cited for noncompliance to safety norms and given two years to fix its problems, which hadn’t been resolved when an agency review took place in March, according to the paper. But in a statement, BestPharma claimed those problems had been solved and the rest were in the process of being corrected. The company plans to take legal action once all issues are corrected.

Facing closure, the paper reports that BestPharma may try to set up shop under a different name. “They can do it, but they need the authorization from this institute, and today’s requirements aren’t the same as in the 1980s when they first got their permit,” Heitmann said.

Source: The Santiago Times