Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards ofeach drug product to determine the need for changes in specifications or manufacturing or control procedures.
The responsibilities and procedures applicable to the quality control unit are not fully followed.
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.
Complaint records are deficient in that they do not include the findings of the investigation and follow- up.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Employees are not given training in the particular operations they perform as part of their function.
Extracted automatically from the document US FDA published on 2017-12-05. 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.
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