Resources

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 […]

FDA published 4 warning letters this week: 2 were issued for unapproved new drugs2 were issued to drug firms addressed below DRUGS: Ei LLC (Kannapolis, NC) received a warning letter on April 16th, 2018 based on the outcome of an inspection ending October 6th, 2017. Based on the nature of manufacturing and the identified deficiencies, […]

Laws, Regulations, Guidance, and Concept Papers A lite week for new guidance publications: 2 each from FDA and EMA. Among the non-guidance publications are 2 of particular interest: 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in […]

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. [supsystic-tables id=9 ] Like This & Want More? Sign up to get […]