1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
Inspection Record
Global Pharma Healthcare Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment 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.
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product.
4Laboratory and QC controls
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of drug product containers and closures used in the manufacture, processing, packing, or holding of drug products.
5Quality unit oversight
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
6Laboratory and QC controls
Established specifications, standards, sampling plans, test procedures, laboratory control mechanisms, are not followed, documented at the time of performance.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Laboratory and QC controls
The accuracy, sensitivity, specificity, reproducibility, of test methods have not been established.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
10Equipment and facility
Equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use.
11Quality unit oversight
The quality control unit lacks the responsibility and authority to approve, reject all components, drug product containers, closures, in process materials, packaging material, labeling, drug products.
About this record
Extracted automatically from the document US FDA published on 2023-03-30. 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.
