WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
AUROBINDO PHARMA LIMITED, UNITS III AND VI, RECEIVE WARNING LETTER (MAY 20, 2011)
 AUROBINDO PHARMA RECEIVES IMPORT BAN FOLLOWED BY WARNING LETTER  -- AN UNUSUAL SEQUENCE OF EVENTS COMMENT The receiving of an Import Ban prior to receiving a Warning Letter has not been a common occurrence. However, because of the FDA's recent and previous audits, and the lack of continuing compliance, … [Read more...]
FDA ISSUES WARNING LETTER FOR CLINICAL SUPPLY MANUFACTURING FACILITIES — FEBRUARY 10, 2011
Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
