1Labeling and packaging
Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.
Inspection Record
New England Life Care Inc. dba Advanced — FDA 483 Findings
Inspectors Jonathan G Matrisciano · Daniel L Zheng · Terry BridgewaterThe 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been aheady distributed.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
7Equipment and facility
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
About this record
Extracted automatically from the document US FDA published on 2022-10-28. 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.
