1Material and supplier control
Supplier qualification do not include evaluations that provide adequate evidence that the manufacturer can consistently provide material meeting specifications.
Inspection Record
Smithfield Biosciencs, Inc. — FDA 483 Findings
Inspectors Logan Williams · Anna SpirosThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Process Validation performed does not demonstrate that critical process parameters produce consistent APIs meeting their specifications and quality.
3Documentation and records
Batch records and laboratory records of critical steps are not reviewed and approved by the quality unit appropriately.
4Stability and storage
The stability program to justify assigned expiration or retest dates is not followed.
5Training and personnel
There is an inadequate number of personnel to manufacture and test APIs adequately.
6Other quality system
REPEAT OBSERAVTION FROM FDA 2019 INSPECTION***
About this record
Extracted automatically from the document US FDA published on 2026-07-27. 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.
