1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile are not established and followed.
Inspection Record
Baxter Oncology GmbH — FDA 483 Findings
Inspectors Karen A Briggs · Vivin George · Justin A BoydThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned and maintained at approp1iate inte1vals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drng product.
3Material and supplier control
Laborato1y controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials confo1m to approp1iate standards ofidentity, strength, quality and pmity.
4Equipment and facility
Buildings used in the manufacture, processing, packing or holding of diug products ai·e not free ofinfestation by rodents, birds insects, and other ve1min.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile did not include adequate validation ofthe aseptic and sterilization process.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
7Process validation
Your fnm failed to establish adequate w1itten procedures for production and process controls designed to assure that the dmg products have the identity, strength, purity, and quality that they are purpo1ted or represented to possess.
8Equipment and facility
Equipment used in the manufacture, processing, packing or holding of di11g products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
9Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any ofits components to meet any ofits specifications whether or not the batch has been already distiibuted.
10Documentation and records
Procedures for the preparation ofmaster production and control records are not followed.
11Quality unit oversight
The quality control unit lacks authority to review production records to assure that no e1rnrs have occuned.
About this record
Extracted automatically from the document US FDA published on 2026-02-02. 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.
