"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...
From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...
Mumbai: Cipla, an Indian multinational pharmaceutical company, has announced that the United States Food and Drugs ...
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
Piramal Pharma slipped 1.14% to Rs 195.40 after the US FDA issued a Form-483 with 6 observations to the company's Turbhe facility post a GMP inspection.
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
At the conclusion of the inspection, FDA investigators issued a Form 483, Inspectional Observations, detailing the deficiencies observed. Employees working with food products were observed failing ...
Piramal Pharma's Turbhe facility in Navi Mumbai receives six observations from U.S. FDA inspection, company preparing detailed response.
Mumbai: Piramal Pharma has announced that the Company has received six observations from US Food and Drug Administration ...
Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.
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