1Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
Inspection Record
New England Home Therapies, Inc. — FDA 483 Findings
Inspectors Edmund F MrakThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile d o not include validation of the sterilization process.
7Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
8Equipment and facility
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper perfor mance.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
