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News about GMP/cGMP


FDA: Warning Letters for European Drug Manufacturers

Not only China and India are in the focus of the US FDA when it comes to GMP non-compliance. Recently the FDA has released warning letters for cGMP violations identified in Scotland, the Netherlands and Switzerland.


At the manufacturing site of Laboratoire Sintyl SA in Geneva, FDA uncoverd six serious cGMP-violations according to 21 CFR 211, including

  • the failure to test “finished batches for the identity and strength of active ingredients“,
  • the failure to clean and maintain the equipment and
  • the lack of an established written procedure for "production and process controls, including validation protocols and reports, designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess“.

In another Warning Letter that went to the Dutch company Delarange Cosmetics & Healthcare BV , FDA criticized the failure to “establish and follow written procedures for cleaning and maintenance of equipment”. Additionally FDA uncovered, that no quality control unit for drug release was established.

To Scotland-based Wallace Cameron  International the Agency wrote: “Our records indicate that you have not registered your establishment for 2016, but have continued to manufacture, prepare, propagate, compound, or process drugs that were not listed but being imported or offered for import into the United States during this time.” In this context they did not mention which drug has been imported to the US.



FDA: Warning Letters

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