OBJECTIVE: This procedure outlines the procedure for operation of Water Purification System. Make : ADRONA-SIA Model : Q-Front SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible to follow the SOP. The Head of Quality Control Department or his designee shall […]
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Indiana Chem-Port MARCS-CMS 618173 — FEBRUARY 02, 2022 February 02, 2022 WARNING LETTER Delivery Method:Via EmailProduct:Drugs Recipient:Indiana Chem-Port 349 GIDC Industrial Estate Makarpura, Vadodara Gujarat IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-11 AMENDED February 2, 2022 Dear Mr. Desai: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indiana
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Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy DistrictHyderabad 500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January 12,
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Biotek India MARCS-CMS 613295 — MAY 13, 2021 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs Recipient:Biotek India 919/2 First Floor, Conmet Cross Road, Makarpura GIDC Vadodara 390010 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research United States Warning Letter 320-21-45 May 13, 2021 Dear Mr. Arora: Your facility is registered with the United States Food and Drug Administration (FDA) as a
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of the Refrigerator. SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Officer/ Executive shall be responsible for the effective handling, operation, maintenance, calibration and validation
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of Bursting strength apparatus. SCOPE: This SOP is applicable to Bursting Strength Apparatus at manufacturing facility. RESPONSIBILITY: Analyst/Section Head or his designee shall be responsible
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OBJECTIVE: The purpose of this SOP is to lay down a procedure Management of Received, handling, storage and usage of reference standard and reference solution. SCOPE: This SOP is applicable to reference standard and reference solution used at quality control department. RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Suppository Tester Apparatus. SCOPE: This SOP is applicable to Suppository Tester Apparatus (Make: ELECTROLAB, Model No.: ESDT – 3) in Quality Control Department at manufacturing facility of XXX. RESPONSIBILITY: Analyst / Section
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OBJECTIVE: The purpose of this SOP is to lay down a procedure for Operation and calibration of Dissolution Test Apparatus. SCOPE: This SOP is applicable for operation and calibration of Dissolution Test Apparatus at manufacturing site of XXX.
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Disintegration Tester Apparatus. SCOPE: This SOP is applicable to Disintegration Tester Apparatus in Quality Control Department at manufacturing facility of XXX. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible for
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