King Bio Inc. USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Yearly Archives: 2018
CalmSupport.com, LLC USFDA warning Letter 1/11/18
CalmSupport.com, LLC USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »NutraCore Health Products USFDA warning Letter 1/11/18
NutraCore Health Products USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Soothedrawal, Inc. USFDA warning Letter 1/11/18
Soothedrawal, Inc. USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »U4Life LLC dba Mitadone USFDA warning Letter 1/11/18
U4Life LLC dba Mitadone USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Guna Inc. USFDA warning Letter 1/11/18
Guna Inc. USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Healthy Healing dba Crystal Star USFDA warning Letter 1/11/18
Healthy Healing dba Crystal Star USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Wong Lap Kwong Medicine Company Limited USFDA warning Letter 1/11/18
Wong Lap Kwong Medicine Company Limited USFDA warning Letter 1/11/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Beauty Manufacturing Solutions Corp. USFDA warning Letter 1/12/18
Beauty Manufacturing Solutions Corp. USFDA warning Letter 1/12/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Daito Kasei Kogyo Co Ltd USFDA warning Letter 1/18/18
Daito Kasei Kogyo Co Ltd USFDA warning Letter 1/18/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Polaroisin International Co., Ltd. USFDA warning Letter 1/25/18
Polaroisin International Co., Ltd. USFDA warning Letter 1/25/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Celltrion Inc. USFDA warning Letter 1/26/18
Celltrion Inc. USFDA warning Letter 1/26/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Cosmecca Korea Co., Ltd. USFDA warning Letter 2/2/18
Cosmecca Korea Co., Ltd. USFDA warning Letter 2/2/18 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Imprimis Pharmaceuticals USFDA warning Letter 12/21/17
Imprimis Pharmaceuticals USFDA warning Letter 12/21/17 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17
Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17 For Warning Letter Click here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Investra-24hs USFDA warning Letter 12/28/17
Investra-24hs USFDA warning Letter WARNING LETTER The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed …
Read More »Casmara Cosmetics, S.A. USFDA warning Letter 2/12/18
Casmara Cosmetics, S.A. USFDA warning Letter 2/21/18 For Warning Letter Click the Link – Casmara Cosmetics, S.A. 2/12/18 For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Read More »Questions and answers: GMP compliance for active substances (Annex 1: Manufacture of sterile medicinal products)
Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such …
Read More »Questions and answers: GMP compliance for active substances (EU GMP guide part II)
Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured …
Read More »Questions and answers on Data integrity as per EU GMP(European Medicines Agency)
Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation …
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