1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Inspection Record
Pharmaceutic Labs, LLC. — FDA 483 Findings
Inspectors Chad N. ThompsonThe 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 of drug products is not appropriate for the duties they perform.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
5Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility are not written.
6Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
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.
