Medicines and Healthcare products Regulatory Agency
Report No : UK GMP 43979 Insp GMP 43979/11316477-0004 NCR
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
03/09/2018
, it is considered that
it does not comply with the Good Manufacturing Practice
requirements referred to in
-
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The Manufacturer :
EVERTOGEN LIFE SCIENCES LIMITED
Site address :
EVERTOGEN LIFE SCIENCES LIMITED, PLOT NO: S-8, S-9, S-13/P & S-14/P TSIIC, PHARMA SEZ, GREEN INDUSTRIAL PARK, POLEPALLY (V), JADCHERLA (M), , MAHABUBNAGAR, IN-509 301, INDIA
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 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 |
Part 3
Nature of non-compliance:
The inspection on 03-08 September 2018 identified continued extensive failures in the GMP controls applied by the manufacturer. A restricted Statement of Non Compliance was previously issued to allow supply of critical products to EU. However, as no further demand is expected from the site to meet critical needs a full Statement of Non Compliance is now issued.
Withdrawal of current valid GMP certificates:
Withdrawal of previous Statement of Non Compliance and GMP Certificate No: UK GMP 43979 Insp GMP 43979/11316477-0004 NCR and UK GMP 43979 Insp GMP 43979/11316477-0004
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement on non compliance remains in force.
The inspection on 03-08 September 2018 identified continued extensive failures in the GMP controls applied by the manufacturer. A restricted Statement of Non Compliance was previously issued to allow supply of critical products to EU. However, as no further demand is expected from the site to meet critical needs a full Statement of Non Compliance is now issued.
Withdrawal of current valid GMP certificates:
Withdrawal of previous Statement of Non Compliance and GMP Certificate No: UK GMP 43979 Insp GMP 43979/11316477-0004 NCR and UK GMP 43979 Insp GMP 43979/11316477-0004
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement on non compliance remains in force.
| 16/04/2019 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |
Serious, chronic GMP non compliance