1Equipment 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.
Inspection Record
Right Value Drug Stores, Inc. — FDA 483 Findings
Inspectors Patty P KaewussdangkulThe 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
3Quality unit oversight
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
4Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
5Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying a product compounded upon initially registering as an outsourcing facility as required by section 503(b)(2)(A).
6Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA upon initial registration identifying drug products that you compounded during the previous six months as required by section 503B(b)(2)(A).
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.
