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Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2023-10-19

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National Veterinary Medicines Agency

CERTIFICATE NUMBER: 23-343437

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of FRANCE confirms the following:

The manufacturer: Acm Pharma

Site address:

34-36 Avenue Du 21 Aout 1944, Bellegarde, 45270, France

OMS Organisation Id. / OMS Location Id.: ORG-100004844 / LOC-100006004

Has been inspected under the national inspection programme in accordance with Art. 88 of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2018-01-23 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical

Clarifying remarks (for public users):

1.6.1 concerns sterility and endotoxins tests. 1.6.2 concerns efficacy tests for antimicrobial preservatives and microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use. This certificate is valid until June 30th 2024.

Withdrawal comments in English: -

Withdrawal comments in National Language: -

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