NeoChild gets FDA letter questioning brandings, documentation steps

08/17/2008 | FDAnews

The FDA has issued a warning letter to NeoChild, alleging device misbrandings in its SafeChild System line and that the company failed to establish documentation procedures for several good-manufacturing-practice requirements. NeoChild has submitted the title of its appropriate standard procedures for each alleged GMP violation, but the FDA said the company's response was inadequate.

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