1Equipment and facility
The operations relating to the processing and packing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.
Inspection Record
Infusion Options, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed.
3Contamination control
The separate or defmed areas necessary to prevent contamination or mix-ups are deficient.
4Other quality system
Containers and closures are not reviewed for conformance with all appropriate written procedures.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Material and supplier control
There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed.
7Laboratory and QC controls
For each batch of drug product, there shall be appropriate laboratory determination ofsatisfactory conformance to final specifications for the drug product.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
9Labeling and packaging
The labels ofyour firm's drug products do not include information required by section 503B(a)(10) of the Act.
10Aseptic 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.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic 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.
