Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

The inability to conduct onsite inspections impeded investigators’ ability to uncover data integrity issues at manufacturing sites in drug warning letters in FY2021, underscoring the importance of ...

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

Dabur India said the United States Food and Drug Administration (USFDA) issued Import Alert 66-40 for drugs made at part of its Silvassa facility after an inspection flagged data integrity and ...

Intas Pharmaceuticals is facing renewed regulatory pressure in the US after the Food and Drug Administration (FDA) issued a warning letter to its Dehradun facility, flagging serious lapses in quality ...

Documentation remains one of the most scrutinized aspects of clinical trials: Durga Mane: Our Bureau, Mumbai Wednesday, June 24, 2026, 12:10 Hrs [IST] The announcement of a regula ...

Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...

Glenmark Pharmaceuticals Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) ...