1Equipment and facility
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Inspection Record
TAILSTORM HEALTH INC — FDA 483 Findings
Inspectors Michael A CharlesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
concerning retesting] b) Cleaning verification performed to provide evidence that the cleaning methods utilized are effective in removing drug residue in preventing cross contamination from shared equipment used in production of preparations such as Ketamine HCL Injection, Lidocaine HCL Injection and Calcium Chloride Injection incorporated <Redacted B4> sampling followed by analysis.
3Labeling and packaging
The container labels of your outsourcing facility's drug products are deficient.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
5Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
About this record
Extracted automatically from the document US FDA published on 2022-01-07. 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.
