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

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

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 ...

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 ...

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 ...

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.

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 ...

As per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of ...

Issuance of Form 483 observations, warning letters and import alerts from the FDA poses a key risk for Indian pharma companies exporting drugs to US. Form 483 is generally the first indication of ...