The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

Aurobindo subsidiary Aurolife Pharma was issued a Form 483 from the FDA that outlined 11 observations, the Indian drugmaker said in a financial filing.

DexCom explained that it has "already submitted several responses to the Form 483 and is in the process of preparing a written response to the warning letter." It added that it plans "to continue ...

In the event of no findings or deviations during the audit, only an inspection report is given without any FDA Form 483. If there is a serious concern regarding practices or compliance, a warning ...

As per data, 66% of the small and medium FDA-registered facilities in India receive Form 483 observations or fail to respond on time to 483 observations due to a variety of compliance shortcomings.

As per data, 66% of the small and medium FDA-registered facilities in India receive Form 483 observations or fail to respond on time to 483 observations due to a variety of compliance shortcomings.

Applied previously received a Form 483—a less severe FDA reprimand—around its trial conduct and responded to that write-up in May.

With decades-plus-long, legendary track records of poor quality and fraud in the examples listed here, how could the FDA not test everything coming out of China or India without independent ...

The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more. The FDA published the Form 483 on its website Tuesday.

After receiving the 483 form, the company has 15 days to respond. 483 form is not the final explanation of the violation, but it represents the company's urgent attention and resolution.

483 Observations: In addition, FDA’s letter also cited “significant violations” of HCT/P donor screening and eligibility testing and GMP requirements.