"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 ...
The United States Food and Drug Administration (USFDA) inspected the company's topical manufacturing facility in Ahmedabad during December 16-20, 2019, the drug firm said in a BSE filing.
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.
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
Mumbai: Piramal Pharma has announced that the Company has received six observations from US Food and Drug Administration ...
Piramal Pharma's Turbhe facility in Navi Mumbai receives six observations from U.S. FDA inspection, company preparing detailed response.
Piramal Pharma shares will be in focus after the US FDA's GMP inspection at its Turbhe facility from February 11-17, 2025, ...
The company stated that the observations primarily pertain to procedural improvements and are not related to data integrity.
The observations are mainly procedural and do not indicate any data integrity issues, Piramal Pharma added in a regulatory ...