1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and folly followed.
Inspection Record
Nephron Sterile Compounding Center LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
4Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
6Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
7Equipment and facility
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assume compliance with established specifications and standards.
12Laboratory and QC controls
Reserve samples of active drug ingredients are deficient in that they are not retained at least one year after the expiration date of the last lot of the drug containing the active drug ingredient.
13Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
About this record
Extracted automatically from the document US FDA published on 2023-09-25. 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.
