1Stability and storage
Results of stability testing are not used in determining expiration dates.
Inspection Record
Vital Care Compounder LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
4Aseptic 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.
5Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Process validation
I Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
8Equipment 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.
9Training and personnel
Clothing of personnel engaged in the manufacturing, process ing, and packing of drug products is not appropriate ----------~~~~~~~-------------,·~~~~~~~~~~~------1-7.~~~---; EMPLOYEE(S} SIGNATURE
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
11Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
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.
