1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
New England Home Therapies, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
4Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
5Equipment and facility
Buildings used in the processing of a drug product are not maintained in a good state of repair.
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
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.
