Audit Response & FDA Remediation
QualyInc is Hyderabad's emergency response consulting choice when dealing with US FDA Form 483s, official warning letters, or import alerts. We provide technical support to protect your market reputation.
Our consultants draft responses for global regulatory authorities, ensuring every observation is backed by scientific justification, comprehensive root cause evaluations (5-Whys, Fishbone), and structured global CAPA implementations.
Key Deliverables
- FDA Response Documentation: Drafting and editing official response letters to meet the strict 15-day regulatory submission deadline.
- OOS & Contamination Investigation: Deep dive root-cause determinations for out-of-specification results or media fill contamination issues.
- System Remodeling & Oversight: Direct third-party technical oversight to supervise plant validation upgrades.
- Interim Progress Updates: Structured status reporting protocols to update regulatory agencies periodically on CAPA completion metrics.
Need a customized scope proposal?
Our consulting team is based locally in Hyderabad and can perform a baseline visit within 48 hours.
Request a Custom Proposal