1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile did not include adequate validation of the aseptic process.
Inspection Record
TAILSTORM HEALTH INC — FDA 483 Findings
Inspectors Dogbeda F MackenzieThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written procedures are not established for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding ofa diug product.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been akeady distributed.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
5Labeling and packaging
The labels of your outsourcing facility's dt11g products do not include info1mation required by section 503B(a)(I0)(A) of the Federal Food, Drng, and Cosmetic Act (FD&C Act).
About this record
Extracted automatically from the document US FDA published on 2024-12-10. 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.
