Warning Letter: Design and Validation (g1121d)

Tags:

Ofni Systems
 
References
software design and validation
- "...Our inspection disclosed that these devices are adulterated within the meaning of Section 510(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing and storage are not in conformance with the Good Manufacturing Practice (GMP) requirements for the Quality System Regulation as specified in Title 21, Code of Federal Regulation (CFR), Part 820, as follows..."

View the original warning letter.


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