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The Apothecary Shoppe’s facility in Oklahoma has been given a warning letter after an FDA inspection revealed that the firm produces potassium chloride, a drug that appears on the list of drug products that have been withdrawn or removed from the market. Read More
An FDA review into shipments of drugs from a UK company to the U.S. revealed that Wallace Cameron International has not fulfilled its establishment registration and drug listing obligations but continued to manufacture, prepare, propagate and process drugs that were exported to the U.S. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More
Cheng Fong Chemical received a warning letter from the FDA for dirty equipment, poorly maintained facilities and improper investigations into possibly tainted batches of active pharmaceutical ingredients. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More