1Equipment and facility
Written procedu res are not followed fo r the cleaning and maintenance of equipment, including utensils, used i n the manu facture, processing, packing or holding of a drug product.
Inspection Record
Summerton Drug Compounding and Dispensary — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written production and process control procedures are not fo llowed in the execution of production and pr ocess control functions and documented at the time of performance.
3Material and supplier control
There is a fa ilure to thoroughly review the failure of a batch or any of its components to meet any of its specifications wheth er or not the batch has been already distributed.
4Stability and storage
The written stability testing program is not followed.
5Equipment and facility
The calibration of instruments is not don e at a suitable intervals in accorda nce with an e stablishe d writen program and with pr ovisions for remedial action in the event a ccuracy and/or precision limits are not met.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
