Resources

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 […]

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. Enforcement: 3 drug warning lettersA handful of recalls2 consent decree agreementsA few import alertsNothing this week in the […]

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 […]

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 […]

Continued from Part 1… 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 this […]

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 documentsWHO published 1EMA didn’t publish any in the areas we monitorThe non-guidance collection includes the usual from the FDA, EMA, MHRA, and HPRA this weekAmong the more important announcements […]

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 […]

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 manufacturing environment. Everyday I speak […]

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. Among the non-guidance publications this week: The MHRA inspectorate blog provides examples of data integrity failures in the […]

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged fromproducts containing a poisonous or deleterious substance to companies failing to have an HACCP plan. From companies in Washington, Kansas, and more, here they are: Arrow Reliance Inc., Tukwila, Washington – 1 violation:Products are adulterated […]