1Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design and suitably located to facilitate operations for its intended use, cleaning and maintenance.
Inspection Record
Amman Pharmaceutical Industries — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and fo llowed.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
6Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
7Laboratory and QC controls
Establ ished test procedures are not followed.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile did not include adequate validation ofthe aseptic process.
9Documentation and records
Batch production and control records do not include comp lete information relating to the production and control of each batch.
10Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
