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Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare | Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare
Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. It is not clear whether the company also owns an EU GMP certificate. The EudraGMDP neither lists a GMP certificate nor a GMP Non-Compliance Report. But the database is not complete yet. Still, not all countries have entered all their data into this community database. In March, the US FDA published an Inport Altert for Marck Biosciences Limited, Plot No. 876, N.H. – 8, Village Hariyala, Tal Matar, Kheda 387411, India. Now, the FDA has explained why. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Among the GMP deviations observed, the inspectors reported:
- Inspectors found “unofficial” visual inspection records, signed by production personnel, with data that are different from the official batch records reviewed by your firm’s quality unit
- Inspectors revealed the firm's use of scratch paper containing critical manufacturing data. The data on these scratch paper records did not always match the data on the corresponding official batch records
- At the time of the inspection, the firm hired contract employees who had not received any training on cGMP. These contract employees performed critical manufacturing operations, such as sterilizing operations. Moreover, the firm falsified documents designed to demonstrate the effectiveness of CGMP training. The production head admitted to pre-filling out the answers to post-training comprehension assessment questions and entering the names of employees on these documents.
- During the inspection, investigators noted significant mold growth in the washroom located at the entry to the sterile manufacturing area. The ceiling of this room had been allowed to deteriorate to such an extent that it caved in. This room shares a common mezzanine with the adjacent sterile processing rooms.
- The investigators noted numerous dead insects in the “Sample Pass Through” Room, located near to the Sterile Filling Line of the small volume parenterals facility. In addition, dead and decaying frogs were found next to the product exit dock.
- The investigators found numerous loose and uncontrolled labels for multiple products in the open office area adjacent to the packaging lines. Unused labels were not stored in a manner to prevent mix-ups or mislabeling.
The situation observed at the Marck Biosciences can not be considered as a GMP failure only. The company did not implement basic GMP principles,and both the management and employees even falsified data to make sure that the problems will not be discovered by GMP inspectors. By doing so, they put patient safety at risk because products have been released which have not been manufactured according to GMP. Again, Indian Regulators have not identified the problems although the company had been existing for years.
A look to the company website contains some surpring information. Just a few weeks after the US Import Alert was published the company, Marck Biosciences Ltd changed its name to Amanta Healthcare Ltd. The change became effective on June 24,
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发表于 2014-8-21 09:43:45
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