Skip to content
Pharmaceutical Guidelines
Quality Is Policy
  • Home
  • Quality Assurance
    • List of SOP for Pharmaceutical Quality Assurance
    • SOP on Handling of Incidents and Deviations
    • SOP on Change control
    • SOP on Training of Employees
  • SOP Format
  • Quality Control
    • SOP on Cleaning Validation
    • SOP on Analytical Report (AR) Numbering
    • SOP ON Receipt, Issue & Control Of Lab Chemicals
    • SOP for Qualification of Quality Control analyst
    • SOP On Safety In Quality Control Laboratory
  • Production
  • Microbiology
    • SOP on Preparation of Culture Dilution
    • SOP on Microbial Testing of Drain Water
    • SOP ON BIO-BURDEN OF PACKING MATERIAL
  • Maintenance
  • EDQM
  • Analytical Method Validation
  • Process Validation
  • Drug Regulatory Affairs
  • ICH
  • cGMP
  • WHO
  • Blog
  • Contact Us
  • Privacy Policy

Category: FDA Warning Letter

FDA WARNING LETTER – Shilpa Medicare Limited

November 7, 2020 Admin Leave a comment

Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing…

Continue Reading →

Posted in: FDA Warning Letter Filed under: FDA Warning Letter, QMS, Quality Assurance, Shilpa Medicare Limited Warning Letter 2020

WARNING LETTER

October 5, 2020 Admin Leave a comment

Pfizer Healthcare India Private Limited Warning Letter 2020 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility,…

Continue Reading →

Posted in: FDA Warning Letter Filed under: Pfizer Healthcare, Warning Letter

Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

September 11, 2020 Admin Leave a comment

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 23, 2020, to Tender Corporation. The…

Continue Reading →

Posted in: FDA Warning Letter Filed under: FDA Warning Letter, Quality Control, Unofficial HPLC Injection, USFDA Audit

Pages

  • Analytical Method Validation
  • Blog
  • cGMP
  • Contact Us
  • Drug Regulatory Affairs
  • EDQM
  • Home
  • ICH
  • List of ICH Quality Guidelines for Pharmaceutical Industry
  • Maintenance
  • Microbiology
  • Privacy Policy
  • Process Validation
  • Production
  • Quality Assurance
  • Quality Control
  • SOP Format
  • SOP List For Pharmaceutical Quality Assurance
  • SOP on Change control
  • SOP on Handling of Incidents and Deviations
  • SOP on Training of Employees
  • WHO

Pages

  • Analytical Method Validation
  • Blog
  • cGMP
  • Contact Us
  • Drug Regulatory Affairs
  • EDQM
  • Home
  • ICH
  • List of ICH Quality Guidelines for Pharmaceutical Industry
  • Maintenance
  • Microbiology
  • Privacy Policy
  • Process Validation
  • Production
  • Quality Assurance
  • Quality Control
  • SOP Format
  • SOP List For Pharmaceutical Quality Assurance
  • SOP on Change control
  • SOP on Handling of Incidents and Deviations
  • SOP on Training of Employees
  • WHO

Tags

Analyst Qualification Audit Preparation Calibration CAPA Change Management System Cleaning Validation Compression Machine Computerized System EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Operation Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
  • Home
  • Quality Assurance
  • SOP Format
  • Quality Control
  • Production
  • Microbiology
  • Maintenance
  • EDQM
  • Analytical Method Validation
  • Process Validation
  • Drug Regulatory Affairs
  • ICH
  • cGMP
  • WHO
  • Blog
  • Contact Us
  • Privacy Policy
Privacy Policy
Copyright © 2018 - 2020 Pharmaguideline