Ciba blend validation procedures "inappropriate" at Swiss manufacturing facility, FDA warning letter alleges.
CIBA-GEIGY BLEND VALIDATION PROCEDURES "INAPPROPRIATE" at Stein, Switzerland oral solid dosage form manufacturing facility, a March 1 FDA warning letter charges. "Your stated limits for blend assays and RSDs [relative standard deviations] for blend homogeneity validation studies do not conform with current FDA expectations....We consider this inappropriate," the letter states. FDA inspected Ciba-Geigy AG's manufacturing facilities at Stein and Schweizerhalle, Switzerland between Oct. 24-31, 1994.
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