1Training and personnel
Clothing of personnel engaged in the of drug products is not appropriate for the duties they perform.
Inspection Record
Pentec Health, Inc. — FDA 483 Findings
Inspectors Anita R. Michael · Julianne C. McCulloughThe 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 and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3Stability and storage
There is no written testing program designed to assess tbe stability characteristics of drug products.
4Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not includ e adequate validation of the sterilization process.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any ofits components to meet any ofits specifications v.nether or not the batch has been already distributed.
7Other quality system
Sampling and testing plans for drug products are not described in written procedures which include the method ofsampling and number:ofunits per batch to be tested.
8Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.
9Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
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.
