1Training and personnel
Employees are not given training in written procedures required by current good manufacturing practice re gulations.
Inspection Record
Kings Park Slope Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
3Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying a product(s) compounded during the previous six months for the December 2015 reporting period as required by section 503B(b)(2)(A).
4Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
5Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B (a)(10) ( A) and (B).
6Process 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.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment Sporicidal disinfection of aseptic manufacturing areas is only performed redacted b4.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
