1Documentation and records
The master production and control records are not followed.
Inspection Record
Mixlab WI LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture processing, packing or holding of a drug product.
5Material and supplier control
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
7Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
About this record
Extracted automatically from the document US FDA published on 2026-07-01. 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.
