Month: February 2022

USFDA Warning Letter of Indiana Them-port 2022

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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USFDA Warning Letter of Aurobindo Pharmaceutical Limited 2022

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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USFDA Warning letter for Biotek India

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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SOP For Operation and Calibration of Refrigerator.

  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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SOP For Operation and Calibration of Bursting Strength Apparatus

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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SOP For Management of Reference Standard and Reference Solution

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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SOP For handling, Operation, maintenance and Calibration of Suppository Tester Apparatus

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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SOP For operation and Calibration of Disintegration Tester Apparatus

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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SOP For Operation and Calibration of Bulk Density Apparatus

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling, Operation, and Calibration of Bulk Density Apparatus. SCOPE: This SOP is applicable to Bulk Density Apparatus in Quality Control Department at manufacturing facility of XXX.     RESPONSIBILITY:  Analyst / Section Head or his designee shall be responsible to …

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