1Documentation and records
Master production and control records Jack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required.
Inspection Record
Professional Disposables International, Inc — FDA 483 Findings
Inspectors Paul C. MourisThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Wrillen procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
4Deviation, CAPA, and investigation
There is a failure to thorough ly 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 .
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.
