1Equipment and facility
The calibration of instruments, apparatus, and gauges is not done at suitable intervals .
Inspection Record
The Wellness Center Pharmacy, Inc., dba Designer Drugs — FDA 483 Findings
Inspectors Brandon C. HeitmeierThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations ·for its cleaning and maintenance.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
5Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
6Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
7Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the duties they perform.
8Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
9Equipment and facility
Equipment for adequate control over air pressure and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
12Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach .active ingredient prior to release.
13Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
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.
