1Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
Inspection Record
Family Pharmacy of Statesville — FDA 483 Findings
Inspectors Joanne E. KingThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The calibration of instmments, apparatus, gages and recording devices is not done at suitable intervals in accordance with an established written program.
3Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worse case activities and conditions that provide a challenge to aseptic operations.
4Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
5Aseptic processing and sterility assurance
Your firm failed to confnm that the quality of water was suitable for its intended use in the production of nonsterile drug products.
6Other quality system
You have no assurance that the endotoxin level of your intrathecal drug products is safe, since you do not have any endotoxin data and your firm doesn't perform endotoxin testing for the finished product.
7Other quality system
Air is recirculated to production areas, without adequate measures to control recirculation of dust.
8Contamination control
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
9Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
About this record
Extracted automatically from the document US FDA published on 2020-12-29. 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.
