Medicines and Healthcare products Regulatory Agency
Report No : Insp GMP 52165/19076958-0001
STATEMENT OF NON-COMPLIANCE WITH GMP
Part 1
Issued following an inspection in accordance with :
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
23/06/2026
, it is considered that
it does not comply with the Good Manufacturing Practice
requirements referred to in
-
Regulation 331 of The Human Medicines Regulations 2012 (SI 2012/1916)
The Manufacturer :
Geno Pharmaceuticals Private Limited
Site address :
Geno Pharmaceuticals Private Limited, Tivim Industrial Estate, Karaswada, Mapusa, Goa, IN-403526, INDIA
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17(3) of the Human Medicines Regulations 2012 (as amended)
Part 2
| 1. MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.13 ] Tablets |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.2 ] Secondary packing |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
Restrictions or remarks:The inspection scope encompassed manufacturing, packaging, warehousing and QC operations within the non sterile solid dosage facility.
Activities relating to semi solid dosage forms were excluded from the scope of this inspection.
Part 3
Nature of non-compliance:
An unannounced inspection of the facility was conducted from 15 to 23 June 2026. This inspection was triggered following three Class II recalls of medicinal products supplied to the UK market. Five critical deficiencies were identified, including: - Senior Management had failed to ensure that there was a comprehensively designed and correctly implemented Pharmaceutical Quality System - Lack of adequate and effective procedures and controls to prevent mix-ups and substitution of materials - Failure to ensure that risks of contamination and cross-contamination were assessed and minimised - Deficiencies in the management and investigation of serious quality defects - Generation and retention of unreliable GMP records, compromising data integrity and assurance of product quality
Withdrawal of current valid GMP certificates:
The site does not hold a manufacturing authorisation because it is located in a 3rd country. The MHRA has not issued a GMP certificate for this site. EU Competent Authorities should consider a withdrawal of the current EU GMP certificate.
Prohibition of supply:
No further batches to be supplied to the UK market until an inspection confirms adequate corrective and preventative actions have been taken.
An unannounced inspection of the facility was conducted from 15 to 23 June 2026. This inspection was triggered following three Class II recalls of medicinal products supplied to the UK market. Five critical deficiencies were identified, including: - Senior Management had failed to ensure that there was a comprehensively designed and correctly implemented Pharmaceutical Quality System - Lack of adequate and effective procedures and controls to prevent mix-ups and substitution of materials - Failure to ensure that risks of contamination and cross-contamination were assessed and minimised - Deficiencies in the management and investigation of serious quality defects - Generation and retention of unreliable GMP records, compromising data integrity and assurance of product quality
Withdrawal of current valid GMP certificates:
The site does not hold a manufacturing authorisation because it is located in a 3rd country. The MHRA has not issued a GMP certificate for this site. EU Competent Authorities should consider a withdrawal of the current EU GMP certificate.
Prohibition of supply:
No further batches to be supplied to the UK market until an inspection confirms adequate corrective and preventative actions have been taken.
| 25/06/2026 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |