1Other quality system
The general safety test is not performed according to procedures.
Inspection Record
Greer Laboratories, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
There is no assurance that required testing as performed on samples that are representative of the final released prduct.
3Deviation, CAPA, and investigation
Failure to conduct investigations into unexplained discrepancies or the failure of a batch or any of its components to meet speci fica tions: For example, A.
4Laboratory and QC controls
Lab oratory contro ls do not include scientifically sound and appropriate specifications, stan dards, sampli ng plans, and test procedures designed to assure components and products conform to appropriate standa rds of identity, strength, quality and purity.
5Laboratory and QC controls
Out of speci fication test results are invalidated without determi ning a definitive laboratory error.
6Material and supplier control
Cettificates oftesting of closures are accepted in lieu oftesting without establishing the reliability of the suppl ier's test results through appropriate validation of the test results at appropr iate interval s.
7Aseptic processing and sterility assurance
Facilities des igned to prevent contaminat ion or mix-ups are deficient regarding aseptic processing ofdrug products.
8Deviation, CAPA, and investigation
Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintai ned.
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.
