CGMP deviations: Lack of potency testing.
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CGMP deviations: Lack of potency testing.
CGMP deviations: Lack of potency testing.
CGMP deviations: Lack of potency testing.
Class I - Dangerous
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class I - Dangerous
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.