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**No refrigeration required: our strains have been stabilized to still be potent at room temperature
Key regulations cited Warning letters frequently reaffirm that poorly controlled utilities or weak lifecycle validation undermines process control , even when not the first citation in the letter: Key regulations cited When the FDA writes do not conform to CGMP, they are tying the firms operations back to 21 CFR Parts 210 and 211 , which form the backbone of U.S
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