1Equipment and facility
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Inspection Record
Tarmac Products, Inc — 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.
3Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
4Material and supplier control
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
About this record
Extracted automatically from the document US FDA published on 2026-07-14. 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.
