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identified through a sound statistical sampling plan (or otherwise every finished batch)
must be verified for each sample matrix by qualified personnel
components
monitoring
16.0 - GMP Records for Supplements supplier approval identified through a sound statisticalYou must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records. You must have all records required readily available during the retention period for inspection and copying by FDA when requested
US$ 2500.00
US$ 6000.00
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US$ 1400.00