1Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Inspection Record
SterRx LLC — FDA 483 Findings
Inspectors Edmund F Mrak · Pushpa S JayasekaraThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
There was a failure to handle and store components and closures at all times in a manner to prevent contamination.
3Equipment and facility
Routine calibration and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
6Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
About this record
Extracted automatically from the document US FDA published on 2023-11-01. 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.
