1Contamination control
Personnel engaged in the making ofradiopharmaceuticals in the Nuclear Pharmacy failed to wear appropriate protective apparel to protect the drug product from contamination.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Finished product sterility testing results were not recorded for the following dispensed radiopharmaceutical batches: A.
3Process validation
The firm has inadequate controls for production ofradiopharmaceuticals in the following areas: (A) controls associated with acceptance ofraw materials into production, (B) in-process controls, and (C) controls over release offinished drug product.
4Aseptic processing and sterility assurance
The following dispensed radiophannaceutical batches failed to meet finished product sterility specifications and no investigation was documented regarding these failures; A.
5Other quality system
Expired chemicals are used in production.
6Environmental monitoring
Environmental monitoring practices are inadequate.
7Aseptic processing and sterility assurance
The firm has no protocol for sampling batches for sterility testing.
8Aseptic processing and sterility assurance
Media fill procedures are inadequate or not always followed.
9Other quality system
Compounding sheets are inadequate.
10Other quality system
The ftrrn has not demonstrated that product container/closure systems are suitable to protect the dosage form throughout its shelflife.
11Aseptic processing and sterility assurance
Gowning practices in the Nuclear Pharmacy are inappropriate for the aseptic processing ofradiopharmaceuticals intended to be sterile.
12Quality unit oversight
There is no designated Quality Control Unit for the Nuclear Pharmacy.
13Material and supplier control
There are no written procedures designed to assure that correct labels, labeling and packaging materials are used for drug products.
14Other quality system
No finished product endotoxin testing results were recorded for the following dispensed radiopharmaceutical batches: A.
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.
