1Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such require~nents.
Inspection Record
Town and Country Compounding and Consultation Services LLC — FDA 483 Findings
Inspectors Liatte Krueger · Nancy F ScheragaThe 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 written and followed.
3Aseptic 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.
4Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
5Aseptic processing and sterility assurance
were There is no formal test method for sterility testing for all products, except for lyophilized products which include HCG and Sermorelin-GHRP-6 (all formulations).
6Other quality system
Drug products failing to meet established.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
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.
