1Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for pyrogens are not written and followed.
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection ofcomponents, drug product containers, and closures.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Equipment and facility
Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
6Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products pillporting to be sterile are not established, written, and followed.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring envirorunental conditions.
9Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards ofidentity, strength, quality and purity at the time ofuse.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
11Laboratory and QC controls
Samples taken of drug products for determination of conformance to written specifications are not representative.
12Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
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.
