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The firm also strayed from its batch manufacturing instructions, allowing a bulk batch that was out-of-specification to get passing results for viscosity and density, the agency said. Read More
In its response to the inspection findings, the company said it would begin sending all batches to the lab for analysis prior to distribution. Read More
The FDA cited a combination drug-device product manufacturer in China for serious testing failures and other violations uncovered in an inspection of its facility northwest of Shanghai. Read More
Indian pharma giant Dr. Reddy’s is still in hot water with the FDA over its API manufacturing plant in Srikakulam, Andhra Pradesh, which netted the firm yet another Form 483 for serious violations. Read More
The FDA hit an over-the-counter drug manufacturer in South China with a Form 483 for multiple violations, including missing operating procedures. Read More
The FDA confirmed that it has suspended inspections of Chinese drug manufacturing facilities until further notice in response to the coronavirus outbreak. Read More
Inventia Healthcare, a drugmaker headquartered in Mumbai, India, was slapped with a Form 483 for serious violations at its Thane, Maharashtra facility, including poor data integrity. Read More
The FDA hit a drug manufacturer in Dresden, Germany with a warning letter for serious violations, including a lack of API and stability testing. Read More