Case Study: Deviation Backlog


 A global pharmaceutical client operating under a Warning Letter was having difficulty reviewing a significant deviations backlog for potential red flags that they suspected could further complicate their remediation effort.

  • We deployed a team of six consultants to ‘work down’ a significant backlog (hundreds) of OOS and Deviations, with the primary goals of:
    • Quickly review the hundreds of documents to look for ‘red flags’ that could require escalation.
    • Recommend remediation action to eliminate these red flag issues.
    • Further classify the backlog as amber and/or green to prioritize pre-FDA audit activity.
    • Train internal OSS and deviation QA staff on proper root cause remediation on OSS and deviation investigation, close-out, and reporting.


Both work streams were completed within 9 months, contributing to the lifting of the Warning Letter ahead of the anticipated timeframe. 

Case Study: Warning Letter Remediation


A global sterile injectable client operating under a Warning Letter needed significant cross-functional support to meet remediation commitments, in addition to ongoing site expansion and corporate systems harmonization activities.  


OQSIE deployed individual contributors and teams broadly across operations: 

  • Project Manager (1) supported the acquisition integration PMO.
  • Business Continuity Expert (1) supported gap assessment and execution of BCP integration activities to align with corporate processes.
  • EHS Expert supported remediation activities/commitments.
  • Industrial Engineers (2) supported new equipment implementation (e.g., visual inspection equipment and sitewide redesign of material and people flow).
  • Aseptic Process Supervisor (1) supported shop floor supervision of process & cleaning activities for improved quality compliance.
  • Aseptic Process Engineers (4) supported aseptic process assessments, identification, and implementation of actions to reduce human error related issues.
  • Project Manager (1) and Tech Writer (1) supported a Supplier Quality Management initiative to align with corporate processes.
  • Validation Engineers (15) supported site expansion and remediation activities including installation, commissioning, and qualification of Parts Washers, and revalidation of all packaging and inspection lines.
  • Tech Writers (6) supported SOP & batch record revisions and alignment with corporate standards.


All work streams were completed on-time, contributing to the lifting of the Warning Letter. 

Project Examples

  1. U.S. – Program Manager led PMO for remediation of 483 Observations.
  2. India – Program Manager led PMO for preparation of FDA audit.
  3. U.S. – Subject Matter Expert guided remediation of Quality System gaps of pharmaceutical client’s transportation system
  4. China – Subject Matter Expert supported API supplier audits ahead of critical product launch.
  5. U.S. – Sr. Program Manager organized and operationalized PMO for Warning Letter remediation program while client recruited PMO leader and team members and handed off a fully operational program to client employees.
  6. U.S. – Four Project Managers led several work streams of Warning Letter remediation program.
  7. U.S. – Subject Matter Expert resolved complex CAPAs in the client’s cold chain distribution system.
  8. Brazil – Deployed Portuguese speaking team to perform comprehensive product documentation assessment for compliance gaps and lead gap remediation activity. The team assessed and aligned site quality practices to both the corporate quality manual and ANVISA requirements.
  9. Canada – Program Manager led PMO for Warning Letter remediation.
  10. Austria – Project Manager led remediation of training program.
  11. U.S. – Team of Subject Matter Experts helped to reduce backlog of supplier audits and open CAPAs.