1Laboratory and QC controls
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.
Inspection Record
Farmakeio Outsourcing LLC — FDA 483 Findings
Inspectors Carnerson E MooreThe 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 used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size to facilitate operations for its intended use.
3Equipment and facility
Routine calibration and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2025-12-02. 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.
