FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2019-01-24T16:12:39+00:00

Latest Issue

WEEKLY SCAN | November 3, 2019

Very limited on guidance again this week.  The non-guidance includes some interesting information from FDA, EMA, MHRA and one from PMDA. Enforcement included one warning letter, a handful of recalls and a form 483 that is associated with a warning letter that will likely be published in a week or two.  WHO published five inspection reports, and the EDQM published three reports of GMP non-compliance. Happy Reading, Barb FDA: SAFETY: FDA published a 38-page draft guidance, ‘Best Practices [...]

By |November 12th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

May 22nd, 2019|0 Comments

An evaluation of warning letters associated with data governance and data integrity deficiencies. In this summary, we identify: • [...]

January 22nd, 2019|0 Comments

A detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends [...]

January 8th, 2019|0 Comments

RISK FACTORS USED IN SCHEDULING FDA DRUG GMP INSPECTIONS The global supply chain for drug products sold in the [...]

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