Search FDA Inspections, Sites, and Warning Letters on the FDAzilla Platform
When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
In another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters to four online networks which are marketing unapproved opioid medicines. Also, we include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.
We put together a review of notable 483s from the month of September, including 483s issued throughout the month and most-purchased 483s from the FDAzilla Store.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.
Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.
GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.
Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.
Govzilla welcomes Jonathan Rochez as VP of Engineering.
When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
In another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters to four online networks which are marketing unapproved opioid medicines. Also, we include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.
We put together a review of notable 483s from the month of September, including 483s issued throughout the month and most-purchased 483s from the FDAzilla Store.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.
Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.
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