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Week of May 27th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 6 warning letters this week, 3 of which address human drug manufacturers. Two of these 3 manufacture OTC drug products. We continue to provide the information that FDA requests firms to provide because this provides a roadmap for FDA expectations -- invaluable information for those firms [...]

Part 2: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1... FDA 483 INSPECTION OBSERVATIONS: It all starts with Table 1... Table 1 shows the fifteen (15) most frequent inspection observation citations (the tabulation on the FDA website shows all). Table 1 presents data in the order of those observations with the highest to lowest number [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/27/18

Laws, Regulations, Guidance, and Concept Papers This was a short week in the US with the Memorial Day holiday on Monday: The FDA published 6 guidance documents WHO published 1 EMA didn’t publish any in the areas we monitor The non-guidance collection includes the usual from the FDA, EMA, [...]

By | June 6th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

Week of May 20th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 warning letters this week. Many were issued for unapproved new drugs/misbranding deficiencies. We address 4 below that focused on GMP deficiencies. CELLS/TISSUES: Emmett F. Branigan MD PS Inc (Bellingham, WA) received a warning letter dated May 7th 2018 based on the outcome of an inspection ending [...]

See You At ISPE

Govzilla is on the road again! I hope to see you at the International Society for Pharmaceutical Engineering (ISPE) Quality Manufacturing Conference in Arlington, VA from June 4th - 6th. I am excited because this conference will be tackling challenges in quality manufacturing with a special emphasis on the global [...]

By | May 31st, 2018|Categories: Biopharma / Pharma, CGMP, FDAzilla|0 Comments

GMP Regulatory Newsletter: Summary Scan | Week of 5/20/18

Laws, Regulations, Guidance, and Concept Papers: FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011. EMA published 1 on IMPs for consultation. HPRA, WHO, Health Canada, and CDSCO each published 1. To see the complete list of laws, regulations, guidance, and [...]

By | May 30th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

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