1Equipment and facility
The production area air supply lacks an appropriate air filtration system.
Inspection Record
American CryoStem Corporation — FDA 483 Findings
Inspectors Cody D RickmanThe 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
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, in-process materials and drug products and to prevent contamination.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Material and supplier control
Written procedures are lacking which describe in sufficient detail the sampling and testing of components.
5Process 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.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Material and supplier control
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
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.
