Analyst Reports Successful GMP FDA Audit with No 483s
Analyst Research - A Tentamus Company
(PresseBox) - The FDA informed Analyst Research Laboratories, that following an inspection performed at Analyst, it has determined that the company is in compliance with regards to current good manufacturing practice (CGMP).
During November, 2022, the US Food and Drug Administration (FDA) performed an on-site inspection at Analyst’s facilities in Ness Ziona, Israel. Following this inspection, the FDA informed Analyst it has determined that the inspection classification of this facility is "no action indicated" ("NAI") and that based on this inspection, Analyst is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).
Analyst’s CEO, Dr. Vivi Ziv commented: “We are all excited and honored that the FDA, through this inspection, acknowledged our on-going commitment to excellence. Quality and integrity are our top priority and obligation to our clients, and the outcome of this inspection is yet another evidence for this.”
ABOUT ANALYST
Analyst Research Laboratories is a GCLP, GMP and GLP accredited, FDA-inspected contract laboratory. The >1,000 sqm modern lab specializes in all aspects of analyzing pharmaceuticals, providing a multitude of Analytical & Bioanalytical services to the Pharmaceutical, Biotech, Medical Device, Medical Cannabis and Food Tech industries. Please visit Analyst’s website for further information at https://www.analyst-labs.com
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 90 locations worldwide. More than 4,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Unternehmensinformation / Kurzprofil:
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 90 locations worldwide. More than 4,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Datum: 21.12.2022 - 08:00 Uhr
Sprache: Deutsch
News-ID 673261
Anzahl Zeichen: 2358
contact information:
Contact person: Dr. Vivi Ziv
Town:
Ness Ziona, Israel
Kategorie:
Handcrafts
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"Analyst Reports Successful GMP FDA Audit with No 483s"
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