When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency ...

The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 ...

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. Reddy’s failure to uphold those standards has landed the Indian ...

The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place. The best approach to deal with an observation with which a ...

Strides Pharma Science's Bengaluru facility inspection by the USFDA concluded with five Form 483 observations, which the company plans to address within the stipulated timeline.

Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA. Q. How should a company approach handling an FDA-483 ...

Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re a medical device company with class II or class III products registered with FDA, you need to be ...

Recent warning letters have shed light on common mistakes companies make when responding to 483 findings. Here are a few best practices for addressing FDA’s concerns and mitigating the risk of further ...

Good documentation is an investment. If you need convincing, all you have to do is glance at FDA 483 warning letters, which cite documentation problems with alarming frequency. The good news is that ...

Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations ...

Pfizer said several weeks ago that the FDA had updated the status of its troubled Kansas fill-finish plant, paving the way for drug approvals, and sure enough this week Novartis announced an FDA nod ...