EU Inspection Complaints due to inadequate Handling of OOS Results
Recommendation
13-15 October 2026
Barcelona, Spain
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
On August 08, 2017, a Statement of Non-Compliance with GMP was published on the Eudra GMDP website for Dr. Reddy's Laboratories Ltd. in India.
The findings from several GMP inspections of the manufacturer showed that the company does not operate in compliance with European GMP requirements. The following deficiencies were viewed as critical:
In hundreds of cases, OOS results were systematically invalidated without traceable or scientifically based root-cause-analysis; the only reason given was "staff-errors".
Deviation and OOS management including protocols-, review- and reporting-systems were designed and executed in such a way that all deviations, incidents and unusual events were systematically not documented.
Furthermore, the cleaning of rooms and direct-product-contact equipment had verifiably not been performed.
The consequences include:
- Recall of already released batches
- No deliveries to the EU until a successful re-inspection has been performed
- Withdrawal of the currently valid GMP certificate
Please also see the complete Eudra GMDP "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd. in India.
Related GMP News
05.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus
05.10.2026Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination
30.09.2026The Relationship between the BP and the Ph. Eur.
30.09.2026New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment
30.09.2026EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence