1Process 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.
Inspection Record
Wellcare Rx Investments LLC dba Denson’s Specialty Pharmacy — FDA 483 Findings
Inspectors Debra I. LoveThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
4Other quality system
Specifically, the firm has no data to demonstrate the effectiveness of the sporicide, redacted b4 as a sporicidal agent.
5Documentation and records
The batch production and control records are deficient in that they do not include documentation ofthe accomplishment of each significant step in processing.
6Material and supplier control
Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.Each lot of a component liable to objectionable microbiological contamination is definitely subjected to microbiological tests before use.
7Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written .
10Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size to facilitate cleaning, maintenance, and proper operations.
11Equipment and facility
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
12Aseptic processing and sterility assurance
During a field examination of drug products at your facility the following was observed: Specifically, On 8/ 14/ 15, I observed a vial ofsterile human finished drug product Chlorpromazine HCL 25mg/ml, production lot # 05-070815, prepared on 7/8/15 and expires 10/8/ 15, with what...
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
14Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
15Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing ofdrug products.
16Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
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.
