1Computer 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.
Inspection Record
US Specialty Formulations LLC — FDA 483 Findings
Inspectors James M MasonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate for the duties they perform.
3Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
4Laboratory and QC controls
Laboratory records are deficient in that they do not include the signature of the second person reviewing the record for accuracy.
5Labeling and packaging
The container labels of your outsourcing facility's drug products are deficient.
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.
