1Equipment and facility
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
Inspection Record
Brookfield Medical /Surgical Supply Inc. — FDA 483 Findings
Inspectors Erik W Koester · Jonah S UfferfilgeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.
3Equipment and facility
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
5Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the dmg product.
About this record
Extracted automatically from the document US FDA published on 2022-09-22. 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.
