Resources

FSMA compliance takes a lot of work and determining exactly what food processors, growers, importers, or others in the industry should be doing is something that experts have been writing about. Some articles are purely informational while others provide definitive steps forward. We’ve compiled 8 of the best below: 1. FSMA in a Nutshell In […]

FDA posted 7 warning letters this week. Among those we cover: 1 to an API firm2 to finish pharmaceutical manufacturers1 to a device manufacturer We cover these below. The warning letters issued to drug firms all have significant requirements associated with them that firms are to address. We include these requirements because they provide a […]

We took a snapshot of the 6 warning letters the FDA sent to food companies this month. Food violations ranged from failing to wear beard covers to failing to exclude pests from food plants. From companies in Seattle, New York, and more, here they are: A.C. Calderoni & Co., Brisbane, CA – 3 violations:Firm failed […]

Laws, Regulations, Guidance, and Concept Papers We have another slow week in the publication of guidance: FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compoundingEMA published 1 item addressing pharmacogenomic practicesCDSCO (India) and TGA each published 1 We see the usual collection of non-guidance items from MHRA, EMA, […]

Last week, 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=5 ] Like This & Want More? Sign up to get free weekly content […]

FDA posted 11 warning letters this week: 3 were issued to duodenoscope manufacturers (we identified those last week)2 warning letters went to device firms1 to a contract testing laboratory in France1 to a compounding pharmacy DRUGS/CONTRACT TEST LABORATORY: Quali-Controls & Quali-Controle C.E. BAC (Meru, France) received a warning letter on March 5th 2018 based on […]

This past week, 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=4 ] Like This & Want More? Sign up to get free weekly […]

Laws, Regulations, Guidance, and Concept Papers It’s a very light week for new guidance documents, but do note that the FDA has two in the area of tobacco. The non-guidance publications include the usual collection from FDA, EMA, MHRA, HPRA, and TGA. The FDA also released the form 483 for a recent publication of Biocon’s […]

FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below. Finished Drug Manufacturers: Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome […]

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