1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Eugia US Manufacturing LLC — FDA 483 Findings
Inspectors Daniel L Zheng · Ruben C QuintanaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laborato1y controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and diug products confo1m to appropriate standards of identity, strength, quality and purity.
3Quality unit oversight
There is no quality control unit.
4Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, diug product containers and closures.
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.
6Other quality system
Evidence of reserve diug product sample deterioration was not investigated.
7Equipment and facility
Equipment used in the manufacture, processing, packing or holding of diug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
8Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
9Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a diug product do not have the suitable size and constmction to facilitate cleaning, maintenance, and proper operations.
10Other quality system
Input to and output from the computer and records or data are not checked for accuracy.
About this record
Extracted automatically from the document US FDA published on 2024-01-30. 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.
