1Laboratory and QC controls
Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
Inspection Record
Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Procedures designed to prevent microbiological contamination of drug products purporting to be sierile are not established and followed.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
4Equipment and facility
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
5Quality unit oversight
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, of examination by the quality control unit before release for manufacturing or packaging.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
7Stability and storage
An adequate number ofbatches of-each drug product are not tested nor are records ofsuch data maintained to determine an ..
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
