1Material and supplier control
You used a non~pharmaceutical grade component in the formulation of a drug product.
Inspection Record
Infusion Treatment Center Inc dba ITC Compounding — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
3Process validation
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.
4Training and personnel
Employees are not given training in current good manufacturing practices (GMP).
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
About this record
Extracted automatically from the document US FDA published on 2019-09-15. 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.
