cGMP Quality Assurance and FDA 483s

/cGMP Quality Assurance and FDA 483s

GMP Regulatory Newsletter: Summary Scan | Week of 6/10/18

Laws, Regulations, Guidance, and Concept Papers A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material! Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products. The non-guidance area includes the usual collection from MHRA (including [...]

How to Do A Keyword Search in FDA Warning Letters

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...

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 [...]