1Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Inspection Record
Pentec Health — FDA 483 Findings
Inspectors Lisa B Orr · Christina K TheodorouThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
3Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
