1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Right Value Drug Stores, LLC dba Carie Boyd’s Prescription Shop — 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
2Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifying products compounded during the previous six months as required by section 503B(b)(2)(A).
3Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not established and written.
4Regulatory reporting and change control
Your outsourcing facility has not submitted an adverse event report to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 as required by section 503B(b)(5).
5Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component.
6Aseptic processing and sterility assurance
Aseptic processing ai·eas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2020-01-16. 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.
