1Aseptic processing and sterility assurance
There are no written standards or specifications, methods of testing, methods of cleaning, methods of sterilization, and methods of processing to remove pyrogenic properties.
Inspection Record
Synergy Pharmacy Services — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The video observed during this inspection did not show the smoke flow pattern in the ISO 5 area .
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
The video depicted operations of REDACTED (b)(4) which is not the current operation described on site for the aseptic fill of Glutathione Sterile Inhalation solution REDACTED (b)(4)).
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the areas and equipment to produce aseptic conditions.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
9Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
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.
