FDA Enforcement Trends

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 [...]

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 [...]

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 [...]

Week of May 13th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA published 4 warning letters this week: 2 were issued for unapproved new drugs 2 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, it is interesting [...]

Part 1: The FDA and MHRA’s Most Recent Drug Inspection Observations

INTRODUCTION A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including: FDA forms-483 Establishment Inspection Reports Warning Letters Recalls Import Alerts Consent Decree Agreements EU Reports of GMDP Noncompliance  This 3-part article series presents recent publications of GMP drug product inspection data from CDER and MHRA: The CDER data are from drug inspections conducted in FY2017 [...]

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]