including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled ...

VTRS Investors with Losses Encouraged to Contact the FirmSan Francisco, California--(Newsfile Corp. - March 18, 2025) - On February 27, 2025, ...

Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has successfully passed the GMP on-site inspection by South Korea's Ministry of Food and Drug Safety (MFDS) with ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. With a large backlog, we’re anticipating a significant ramping up of inspections in different ...

BioXcel Therapeutics (BTAI) announced that the U.S. Food and Drug Administration has concluded that the inspection of a single ... findings from the independent audit we announced in October ...

Indoco Remedies Limited (Indoco), a fully integrated, research-oriented pharmaceutical company, announced that its clinical research organisation, AnaCipher, located at Hyderabad, has completed its ...

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...