1Equipment and facility
Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
Wells Pharma of Houston LLC — 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
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
3Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
About this record
Extracted automatically from the document US FDA published on 2023-02-03. 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.
