1Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
Inspection Record
Pharmagen Laboratories, Inc — FDA 483 Findings
Inspectors Maya M. Davis · Sharon K. ThomaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Employees are not given training in the particular operations they perform as part of their function and cunent good manufacturing practices.
3Deviation, CAPA, and investigation
The re is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its coniponents to meet a ny of its specifications whether or not the batch has been already distributed.
4Documentation and records
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
5Equipment and facility
Routine calibration and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
6Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
7Complaint and recall handling
A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed .
8Aseptic 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.
9Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
10Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the fmal specifications and identity and strength of each active ingredient prior to release.
11Contamination control
Protective apparel is not worn as necessary to protect drug pr oducts from contamination.
12Laboratory and QC controls
There is no quality control limit.
13Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
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.
