86 New FDA 483s | 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 trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

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

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 via the internet, with or without a prescription. A total of 17 warning letters were posted this week. We cover 3 of them below. DRUGS [...]

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

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 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016. Figure 3B shows this distribution of deficiencies among [...]

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

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 [...]

FDA Sent These 6 Warning Letters to Food Companies | May 2018

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from companies failing to have personnel conform to hygienic practices while on duty to companies failing to clean and sanitize utensils. From companies in the Carolinas, New York, and more, here they are: Performance Nutrition Formulators LLC d.b.a. VMI [...]

By | 2018-06-11T15:06:09+00:00 June 11th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

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

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

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

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