Pharma Blog

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Pharma Blog 2018-02-26T09:29:08+00:00

PHARMA/BIOTECH

BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…

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  • New FDA 483s

86 New FDA 483s | June 18th 2018

June 18th, 2018|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free [...]

  • Warning Letters

Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

June 15th, 2018|

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. FDA reminds the public that no one is authorized to sell or distribute opioids [...]

  • The FDA and MHRA’s Most Recent Drug Inspection Observations

FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

June 14th, 2018|

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level. Figure [...]

1306, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 6/3/18

June 13th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers: A handful of guidance documents published this week from the FDA, EMA, and ICH. The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial [...]

806, 2018

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

June 8th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

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 that may find themselves with similar challenges. DRUGS: Jalco Cosmetic [...]

706, 2018

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

June 7th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Warning Letters, Form FDA 483, Medical Devices|

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 for 2017, modified as described in the ‘Introduction’ section of [...]

606, 2018

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

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

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, MHRA, and HPRA this week Among the more important announcements [...]

506, 2018

88 New FDA 483s | June 5th 2018

June 5th, 2018|Categories: Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

106, 2018

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

June 1st, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

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 January 31st 2018. Though not stated directly, it appears that [...]