Glukem Biocare: pellet plant barred from EU supply
Maltese inspectors found residue inside a cleaned fluid-bed coater at this Indian pellet maker. No batch from the site may be released to EU markets.
What EU regulators found
- Critical: a pool of liquid and residue sat in the inlet air plenum of a fully cleaned fluid-bed coater. The plenum design does not drain, and the cleaning procedure missed it.
- The fluid-bed coaters had no real-time pressure monitoring to show a failed HEPA filter.
- Eleven major findings, from batch records and process validation to cleaning validation, vendor qualification and identity testing of starting materials.
- The site holds no valid EU GMP certificate.
Timeline
How it got here
15 SEP 2026
Inspection ends
16 OCT 2026
Malta issues the statement of non-compliance: no EU supply, no new marketing authorisations naming the site