Nephron Sterile Compounding Center LLC — FDA 483 Findings

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

Laboratory records are deficient in that they do not include the initials and signature of the <Redacted B4> person reviewing the record for accuracy.

All records of production and control associated with a batch of drug product were not maintained at <Redacted B4> after the expiration date.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Test procedures relative to appropriate laboratory testing for sterility are not written and followed.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.