No procedure for Quality

Warning Letter: Failure establish and maintain records (ucm166530)

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Failure to evaluate and select suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 C.F.R. 820.50(a)(1). 17) Failure to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a)(3).

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Warning Letter: Design and Validation (g1121d)

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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..."

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