Inspection Report CorrectiveActions

Inspection Report Corrective
Actions Evaluation
Expedient No.: PE010-1248 ADDRESSEE
REF No.: DICM/INSP/MBP-SLA Legal Representative
Fees form No.: INTERNO
Incoming date: 03/02/2016
COMPANY: IMEXPHARM CORPORATION -
BRANCH III (IMP3)
In relation to the documentation received on August 11th 2016 regarding to the
corrective actions and the proposed time of completion of the inspection
performed at the facilities of Imexpharm Co. – Branch II (IMP3) on February15th
to 19th 2016, we inform you that:
The corrective actions for the following deficiencies and the implementation
timeframe are accepted: 4a, 4b, 5d, 6c, 6e, 6g, 8, 9, 12a, 15c, 17a, 17d, 19, 25,
29.
Considering the corrective actions introduced address all the deficiencies
observed during the inspection, the inspection process will move forward to the
issuance of the GMP certification. Implementation of corrective actions will be
assessed in the next routine inspection.
Madrid, 12th August 2016
INSPECTOR
Signed: María Barbudo Puchades
Supervised by the Head of GMP/GLP Inspection Area

Kết quả (Anh) 1:

Inspection Report CorrectiveActions EvaluationExpedient No.: PE010-1248 ADDRESSEEREF No.: DICM/INSP/MBP-SLA Legal RepresentativeFees form No.: INTERNOIncoming date: 03/02/2016COMPANY: IMEXPHARM CORPORATION-BRANCH III (IMP3)In relation to the documentation received on August 11th 2016 regarding to thecorrective actions and the proposed time of completion of the inspectionperformed at the facilities of Imexpharm co.-Branch II (IMP3) on February15thto 19th 2016, we inform you that:The corrective actions for the following deficiencies and the implementationtimeframe are accepted: 4a, 4b, 5 d, 6 c, 6e, 6 g, 8, 12, 12a, 15 c, 17a, 17 d, 19, 25,29.Considering the corrective actions introduced address all the deficienciesobserved during the inspection, the inspection process will move forward to theissuance of the GMP certification. Implementation of corrective actions will beassessed in the next routine inspection.Madrid, 12th August 2016INSPECTORSigned: María Barbudo PuchadesInclude by the Head of GMP/GLP Inspection Area

Kết quả (Anh) 2:

Inspection Report Corrective
Actions Evaluation
Expedient No .: PE010-1248 addressee
REF No .: DICM / INSP / MBP-SLA Legal Representative
form Fees No .: Interno
Incoming date: 02/03/2016
COMPANY: IMEXPHARM CORPORATION -
BRANCH III (IMP3)
In relation to the documentation received on August 11th 2016 Regarding to the
corrective actions and the proposed time of completion of the inspection
at the facilities of Imexpharm Performed Co. - Branch II (IMP3) on February15th
to 19th, 2016, chúng inform you có:
The corrective actions for the deficiencies and the sau an implementation
timeframe are accepted: 4a, 4b, 5d, 6c, 6e, 6g, 8, 9, 12a, 15c , 17a, 17d, 19, 25,
29.
considering the corrective actions address all the deficiencies introduced
Observed khi the inspection, the inspection process move forward sẽ to the
Issuance of the GMP certification. Implementation of corrective actions Will Be
Assessed in the next routine inspection.
Madrid, 12th August 2016
INSPECTOR
Signed: María Barbudo Puchades
Supervised by the Head of GMP / GLP Inspection Area