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FDA posted 8 warning letters this week, including: 1 API manufacturer1 finished dosage form manufacturer2 compounding pharmacies DRUGS Keshiva Organics Pvt. Ltd (Maharashtra, India) received a warning letter dated March 15th 2018 based on the outcome of an inspection ending May 31st 2017. The firm is an API manufacturer. FDA identifies that inspections in 2011 […]

      A previous blog entry addressed the Office of Pharmaceutical Quality ‘One Quality Voice’ effort, an aspirational view of FDA’s efforts to ensure coordination in the review, inspection, and approval process as well as post-approval oversight of both facilities and products. Shortly after that publication, FDA’s Office of Product Quality published their first […]

Laws, Regulations, Guidance, and Concept Papers A slow week for guidance publication: 2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP […]

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 […]