Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
The written stability program for drug products does not include sample size based on statistical criteria for each attribute examined to assure valid estimates of stability.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
The responsibilities and procedures applicable to the quality control unit are not in writing.
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Extracted automatically from the document US FDA published on 2018-09-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
Growth stages previewSolve a quiz to start hatching
Your growth record is stored safely in this browser.
