Inspection History
The audit record for our API manufacturing site.
Publishing an inspection history only means something if it includes the inspections that went badly. A page listing nothing but clean outcomes tells a reader either that the site is never inspected or that the page is not complete.
Observations raised at any of the inspections below have been closed, and the responses are available to customers on request.
Inspection register
| Date | Inspecting body | Scope | Outcome |
|---|---|---|---|
| March 2026 | Gujarat FDCA | GMP — routine | Closed, no critical observations |
| November 2025 | Customer audit | Supplier qualification | Approved |
| August 2025 | Certification body | ISO 9001:2015 surveillance | Certification maintained |
| February 2025 | Customer audit | Quality system | Approved, 3 minor observations closed |
How we handle audits
Customer audits welcomed
On-site audit is part of qualifying us. We would rather you came and looked than relied on a questionnaire.
Observations tracked to closure
Every observation gets a root cause, a corrective action with an owner and a date, and an effectiveness check afterwards.
Response within 30 days
Written responses to audit observations are issued within 30 days, with interim updates if an action needs longer.
Speak to someone who knows the answer
Technical, regulatory or commercial - your enquiry reaches a person who works on this, not a shared inbox.