1Quality unit oversight
Adequate lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
Inspection Record
Imprimis NJOF, LLC — FDA 483 Findings
Inspectors Helen Verdel · Louis An · Jose M. CayuelaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
3Training and personnel
Production personnel were not practicing good sanitation and health habits.
4Process 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.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch bas been already distributed.
6Equipment and facility
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
7Material and supplier control
Establishment of the reliability of the container closure supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
8Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
10Material and supplier control
Examination of a lot of a component, drug product container or closures liable to contamination with extraneous adulterant is deficiently examined against established specifications for such contamination.
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.
