FDA Warning Letter

Latest Headlines

Latest Headlines

FDA spanks second Novacyl Asian API plant with warning letter

The FDA has cited a Novacyl active pharmaceutical ingredient (API) manufacturing plant in Thailand with a warning letter after finding some of the same issues there that it had uncovered at the company's facility in China.

New FDA concerns arise for Hospira plant in Australia

Hospira has been dealing with FDA concerns for years for plants in the U.S. and more recently in India. But despite being told more than a year ago that it should have a "global corrective action plan" for both its foreign and U.S. plants, new issues have surfaced, this time for a plant in Australia that makes specialty injectable drugs.

India's IPA hires consulting firm to help it overcome bad publicity

Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.

FDA smacks Mexican facility that makes scorpion antivenom for U.S.

The FDA has found problems at the Mexican plant where Anascorp, the only scorpion antivenom available in the U.S., is manufactured, listing more than a dozen observations in a recent warning letter.

FDA takes aim at yet another Indian API maker

The steady string of warning letters issued to Indian drug and ingredient makers as the FDA has added to its staff in India is fueling the perception that the country has issues when it comes to quality. Now another warning letter has been issued.

FDA says Indian drugmaker made up data for API tests

Last year, FDA inspectors said employees at the Canton Laboratories active pharmaceutical ingredient facility in Vadodara, India, were not getting equipment clean enough between batches to prevent cross contamination. The company's certificates of analysis had been showing that its APIs were within limits for microbial and metal content, but there was a problem with those tests: They never occurred.

Amgen responds to FDA warning letter over drug/device combos

Amgen has been issued an FDA warning letter for problems the agency says it found at its plant in Thousands Oaks, CA, which makes prefilled syringes and related devices used for its osteoporosis drug Prolia, and for Enbrel, the autoimmune disease treatment it shares with Pfizer.

EMA makes inspection reports public

The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to  Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.

Another Fresenius plant gets warning letter

German drugmaker Fresenius received a scathing warning letter in July for a drug plant in India. Now, a blood-products plant in Puerto Rico has been sent a warning for a labeling issue which the agency said should have been resolved months, even years ago.

UPDATED: BTG unit gets FDA warning letter for Connecticut plant

In an earnings note today, BTG said its Biocompatibles unit had received an FDA warning letter sometime in the last three months for its plant in Oxford, CT. It said it had voluntarily halted production of brachytherapy products.