1Contamination control
Personnel infrequently changed and sanitized gloves to prevent contamination.
Inspection Record
Empower Clinic Services LCC dba Empower Pharmacy — FDA 483 Findings
Inspectors Camerson E Moore · Demario L WallsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Inadequate post-use <Redacted B4> testing on <Redacted B4> used to sterilize drug products.
3Aseptic processing and sterility assurance
Use of ingredients not intended for pharmaceutical use in sterile drug production.
4Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
5Material and supplier control
Compounding with components, containers or other materials that have not been verified to assure that they do not contribute endotoxin contamination that may be objectionable given the product's intended use.
6Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
7Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
About this record
Extracted automatically from the document US FDA published on 2024-02-12. 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.
