Holding & distribution (21 CFR 111.453)
21 CFR Part 111 Subpart M (§§111.453–111.475) requires dietary supplement holding and distribution to protect against mix-ups, contamination and deterioration: defined storage conditions (temperature, humidity, light) per the stability programme, FEFO/FIFO rotation, lot-level traceability outbound, returned-produ...
21 CFR Part 111 Subpart M (§§111.453–111.475) requires dietary supplement holding and distribution to protect against mix-ups, contamination and deterioration: defined storage conditions (temperature, humidity, light) per the stability programme, FEFO/FIFO rotation, lot-level traceability outbound, returned-product handling per 111.503. The recurring observation is an ambient warehouse storing a refrigerated probiotic without temperature mapping.
- 21 CFR 111.453
- 21 CFR 111.475
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