Inspection Record

Dr. J Skinclinic, Inc — FDA 483 Findings

US FDAInspected 2026-03-23Published 2026-07-13 7 findingsQuality unit oversightTraining and personnelLaboratory and QC controlsProcess validationMaterial and supplier controlStability and storageEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Quality unit oversight

Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.

2Training and personnel

Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.

3Laboratory and QC controls

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

4Process validation

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time ofperformance.

5Material and supplier control

Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

6Stability and storage

Results of stability testing are not used in determining appropriate storage conditions and expiration dates.

7Equipment 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.

About this record

Extracted automatically from the document US FDA published on 2026-07-13. 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.

Dr. J Skinclinic, Inc company profile — full history US FDA documents, 2026 Go to Findings search