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Modern Architecture

FDA Observation Remediation

A Story of Success

Macro photo of tooth wheel mechanism wit

A European based manufacturing bulk raw material in India had an unsuccessful inspection by the US FDA resulting in a number of 483 observations. Subsequently, the distribution of finished products manufactured by any company in the world using the subject raw material for distribution was banned  in the United States.

The scope of  FDA observation were related to:

  • Quality control

  • Validation

  • Documentation

  • Environmental monitoring

  • Equipment qualification

  • CSV

  • Cleaning validation

  • Investigations

  • Training

  • Deviation and OOS, CAPA

  • Change control

  • Facility design

  • Warehouse

  • Utilities

  • Quality culture


ICS Maven Associates performed an in-depth gap assessment of each of the observations and prepared a comprehensive remediation action plan.   Our associate managed the entire remediation plan through a unified collaboration between the head of the firm’s Corporate QA group, site quality management team, and ICS Maven team.  Initially, a detailed response for each observation was prepared, reviewed by the company’s legal advisors and presented to the US FDA  along with the overall remediation action plan. 


​ICS Maven and Associates formed a team of subject matter experts for each action item which included members of site QA, QC and Operation departments. 


The ICS Maven associates were included in all subprojects.  We ensured that the interdependency  of various actions amongst the sub-projects were managed on time and appropriately.  Weekly meetings were held with each sub-project team and an overall weekly update was presented to corporate and site executives.  Quarterly project progress reports were prepared, reviewed by ICS Maven and   the legal team and issued to the FDA.  All observations were remediated in full compliance with the regulations.   All major SOPs were updated and the respective personnel were fully trained accordingly.

Due to the effectiveness of the project at this site, ICS Maven Associates were contracted by the firm’s corporate QA department to perform additional assessments and initiate quality improvement projects in other sites located in Europe, Asia, and North America, specifically with respect to computer system validation.

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