1Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Inspection Record
Reliable Rexall-A Compounding Pharmacy — FDA 483 Findings
Inspectors Lucila B Nwatu · Kristin M AbaonzaThe 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.
3Deviation, CAPA, and investigation
No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of dg products.
4Material and supplier control
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
5Stability and storage
Results of stability testing are not used in determining expiration dates.
6Other quality system
a) You do not conduct any in process testing during production of your capsules to assess the particle size distribution and homogeneity of the blends.
7Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
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.
