1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment I to produce aseptic conditions.
Inspection Record
Medistat RX, LLC — FDA 483 Findings
Inspectors Samlllltha J. Bradley · Samanlha J. BnldleyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
4Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure t hat they are suitable for their intended use using a validated process.
5Labeling and packaging
The labels and containers of your outsourcing facility's drug products do not include information required by section 503B(a)(10) .
6Aseptic processing and sterility assurance
Aseptic processing areas are defic-ient regarding systems for maintaining any equipment used to control the aseptic conditions.
7Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
8Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches ofdrug products meet appropriate statistkal quality contTol criteria as a condition for their approval and release.
9Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its oomponents to meet any ofits specifications whether or not the batch has been already distributed .
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
11Stability and storage
The written stability testing program is not followed.
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.
