1Contamination control
Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
Inspection Record
Veganic SKN Limited — FDA 483 Findings
Inspectors Nibin VargheseThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, drug product closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.
3Material and supplier control
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
4Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
6Quality unit oversight
The quality control unit lacks the responsibility and authority to approve, reject all drug products.
About this record
Extracted automatically from the document US FDA published on 2026-07-28. 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.
