Topic: FDA warning letter
The regulatory quagmire has deepened for the Teva Pharmaceutical sterile injectables plant in Hungary which the FDA banned this year over slipshod manufacturing standards. The FDA has now issued the plant a warning letter.
The FDA named two European drug manufacturers--Delarange Cosmetics & Healthcare of the Netherlands and Wallace Cameron of the U.K.--in separate warning letters, citing poor quality control, filthy equipment and failure to register with the agency.
The FDA has slapped Swiss skin-care manufacturer Laboratoire Sintyl with a warning letter after an inspection of its Geneva plant uncovered records keeping and batch testing issues, and found what appeared to be rust in some equipment.
The FDA has handed down another warning letter to a Chinese drug manufacturer. This time the warning was issued to Yangzhou Hengyuan Daily Chemical Plastic located in the Hanji Industrial Park in Yangzhou.
In response to an FDA warning letter, a Brazilian drug manufacturer told the FDA it has no intention of producing over-the-counter drugs for the U.S. market.
The FDA hit Japanese drug manufacturer Nippon Fine Chemical with a warning letter for obstructing an inspection at its plant last year.
A Taiwanese API maker is in hot water with the FDA, which has issued it a warning letter after an inspection in which investigators found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned.
The FDA put a Chinese biologics drugmaker on import alert and followed up with a warning letter after an inspection a year ago that found serious microbial contamination at its plant in Hebei.
Brazil’s Lima & Pergher was hit with an FDA warning letter in the wake of a February inspection that found significant violations at the company’s manufacturing facility.
The FDA posted another warning letter to Pan Pharmaceuticals that further extends an import alert issued last year, effectively keeping in place a ban on the drugmaker’s products in the U.S.