Dr Reddy's Laboratories Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the ...

A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...

Concluding that the plaintiffs had not sufficiently alleged a connection between the July 2018 Form 483 observations and the August 2021 clinical hold, the Court dismissed the complaint. KEY TAKEAWAYS ...

Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra ...

The U.S. FDA inspected Lupin's Pithampur Unit-2 manufacturing facility from July 08 to July 17, 2025. The inspection closed with the issuance of a Form-483 with four observations.

The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records i ...

An observation on Form 483 may read like this: “Your media fills failed to accurately simulate commercial operations. Our inspection found the aseptic operations simulated during your media fills were ...

The FDA issued a Form 483 last year for Biocon’s plant in Bangalore where it makes biosimilars as well as the autoinjectors for its insulin products.

In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. As per the USFDA, a ...

ETHealthworld.com brings latest form 483 news, views and updates from all top sources for the Indian Health industry.

The USFDA Form 483 is delivered and reviewed with the company's senior management following an inspection. Companies are urged to promptly implement their corrective action plans after responding ...