Tag Archives: Isle of Wight

Pharma USFDA Warning Letter for Essnd Global

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Essnd Global MARCS-CMS 595850 — February 14, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

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Pharma USFDA Warning Letter for JHS Svendgaard Hygiene Products Ltd

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JHS Svendgaard Hygiene Products Ltd MARCS-CMS 593473 — February 13, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more …

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Pharma USFDA Warning Letter for KVK-Tech, Inc

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KVK-Tech, Inc MARCS-CMS 592387 — February 11, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

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Pharma USFDA Warning Letter for Chemland Co., Ltd.

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Chemland Co., Ltd. MARCS-CMS 593158 — February 11, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

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Pharma USFDA Warning Letter for Acino Products, LLC

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Acino Products, LLC MARCS-CMS 589471 — February 10, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

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Pharma USFDA Warning Letter for Guangzhou Tinci Materials Technology

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Guangzhou Tinci Materials Technology Co., Ltd. MARCS-CMS 592199 — January 23, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For …

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Pharma USFDA Warning Letter for Windlas Healthcare Private Limited

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Windlas Healthcare Private Limited MARCS-CMS 595494 — March 10, 2020   For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more …

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Pharma USFDA Warning Letter for Cipla Limited

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Cipla Limited MARCS-CMS 597511 — February 25, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

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Pharma USFDA Warning Letter for Hangzhou Linkeweier

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Hangzhou Linkeweier Daily Chemicals Co., Ltd. MARCS-CMS 595492 — March 13, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For …

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Pharma USFDA Warning Letter for Derma Pharm

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Derma Pharm A/S MARCS-CMS 596662  March 10, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter …

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Pharma USFDA Warning Letter for Pfizer Healthcare India Private Limited

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Pfizer Healthcare India Private Limited MARCS-CMS 594972 — March 25, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more …

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Pharma USFDA Warning Letter for Trilogy Laboratories, LLC

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Trilogy Laboratories, LLC MARCS-CMS 595087 — March 05, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

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Pharma USFDA Warning Letter for FICOSOTA LTD

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  For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

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Pharma USFDA Warning Letter Global Treat Srl

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Global Treat Srl MARCS-CMS 596638 — March 31, 2020 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …

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Pharma Factory Acceptance Test for Automatic Strip Packing Machine

Factory Acceptance Test for Automatic Strip Packing Machine machine name AUTOMATIC STRIP PACKING MACHINE Client Name & Address M/S. document name factory acceptance test PROTOCOL no. SCT/FAT/000 Revision no. 00 MACHINE SR. NO. Table of Contents Sr. No. Title Page No. 1.0         Purpose 2.0         Scope 3.0         Responsibilities 4.0         System description …

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SOP for Performance Qualification for Automatic Strip Packing Machine

Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS Approval Objective Responsibility System Description – Equipment Identification & Description of Operation Standard Operating Procedure Established During Operation Qualification Validation Plan and Methodology Performance Qualification Procedure -1.Effect of Sealing Temperature 2. Effect of Sealing Temperature 3.Effect of Vibration Deviation and …

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Questions and Answers on coronaviruses (COVID-19) WHO

Questions and Answers on coronaviruses (COVID-19) WHO 1.0 Question : What is a coronavirus? Answer :  Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases …

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SOP on Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

SOP on Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home Published 9 April 2020 From: Medicines and Healthcare …

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WHO Pharma Guideline for Basic protective measures against new coronavirus and Myth busters

WHO Pharma Guideline for Basic protective measures against new coronavirus and Myth busters To prevent infection and to slow transmission of COVID-19, do the following: Wash your hands regularly with soap and water, or clean them with alcohol-based hand rub. Maintain at least 1 metre distance between you and people …

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SOP for Performance Qualification for Auto Coater 48’’ GMP Model

SOP for Performance Qualification for Auto Coater 48’’ GMP Model TABLE OF CONTENTS 1.Approval 2.Objective 3.Responsibility 4.System Description – 1.Equipment Identification 2.Description of Operation 5.Standard Operating Procedure  Established During Operation Qualification 6.Validation Plan and Methodology 7.Performance Qualification Procedure Gun Distance from Bed RPM of Peristaltic pump and Spray Rate Effect …

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