1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and the equipment to produce aseptic conditions.
Inspection Record
US Stem Cell Clinic, LLC — FDA 483 Findings
Inspectors Colleen M. AspinwallThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
3Quality unit oversight
There is no quality control unit.
4Other quality system
Procedures describing the handling of written and oral complpaints related to drug products are no t written or followed.
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.
6Material and supplier control
Written procedures are lacking which describe in sufficient detail the identification, storage, approval and rejection of components.
7Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
10Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not a ppropriate f or the duties they perform.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
12Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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.
