1Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Inspection Record
Symrise, S. de R.L de C.V. — FDA 483 Findings
Inspectors Kara D. DobbinThe 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
Failure to conduct process validation on the drng manufacturing process.
3Documentation and records
The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans, and test procedures designed to assure that in-process materials, labeling, and drug products conform_ to appropriate standards of identity, strength, quality and purity.
5Quality unit oversight
Lack of Quality Unit oversight and control ofdocuments.
About this record
Extracted automatically from the document US FDA published on 2025-05-28. 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.
