1Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
Inspection Record
Custom RX LLC, dba Custom RX Compounding Pharmacy — FDA 483 Findings
Inspectors April L. YoungThe 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
Written procedures are not established that describe the tests to be conducted on appropriate samples ofin-process materials ofeach batch.
3Laboratory and QC controls
In-process materials are not tested for identity, strength, quality, and purity and approved or rejected by the quality control wlit during the production process.
4Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laborator y testing.
5Equipment and facility
Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition.
6Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
7Laboratory and QC controls
Laboratory controls do not include the establishment ofscientificaUy sound and appropriate specifications designed to assure that components conform to appropriate standards ofidentity, strength, quality and purity.
8Equipment and facility
The operations relating to the manufacture, processing, and packing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.
9Other quality system
In-process specifications are not consistent with drug product final specifications.
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.
