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
Carie Boyd Pharmaceuticals — FDA 483 Findings
Inspectors Camerson E MooreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
3Equipment and facility
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
5Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A).
About this record
Extracted automatically from the document US FDA published on 2024-07-26. 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.
