1Aseptic processing and sterility assurance
Aseptic processing aresa are deficient regarding the system for monitoring environmental conditions.
Inspection Record
California Stem Cell Treatment — FDA 483 Findings
Inspectors William F Lagud · Cynthia JimThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
3Material and supplier control
The identitiy of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
4Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, s torage, handling, sampling, testing, approval and rejection of components.
5Documentation and records
The batch production and control records are deficient in that they do not include d ocumentation of the accomplishment of each significant step in manufacturing, processing, pa cking and holding.
6Equipment 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.
7Training and personnel
Employees are not given training in current good manufacturing practices.
8Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specification, sampling plans and test procedures designed to assure that components and i n-process materials conform to appropriate standards of identity, strength, quality and purity.
9Complaint and recall handling
Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.
10Quality unit oversight
There is no quality control unit Specifically, Your firm does not have an established quality control unit which has the responsibility and authority to approve or reject all components, in-process materials, labeling, or procedures or specifications which could impact the identi...
11Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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.
