1Contamination 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.
Inspection Record
SterRx, LLC — FDA 483 Findings
Inspectors Edmund F Mrak · Lori M NewmanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The written stability program for drug products does not include meaningful test methods.
3Equipment and facility
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Complaint and recall handling
Complaint records are deficient in that they do not include the known reply to complainant.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency pa1ticulate air filters under <Redacted B4> pressure.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
10Equipment and facility
Substances required for equipment operations such as lubricants and coolants come in contact with components and closures so as to alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.
11Training and personnel
Employees are not given training in the particular operations they perform as particles of their function.
About this record
Extracted automatically from the document US FDA published on 2022-03-02. 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.
