1Validation and qualification
The number of qualified personnel is inadequate to supervise the manufacture, processing, packing and holding of each drug product.
Inspection Record
RXQ Compounding LLC — FDA 483 Findings
Inspectors Jazmine N. Still · Sarah E. RhoadesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
3Training and personnel
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
4Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength) quality or purity of the drug product.
5Laboratory and QC controls
Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.
6Equipment and facility
Routine checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
7Labeling and packaging
The container labels of your outsourcing facility's drug products are deficient.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
9Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.
10Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2019-11-27. 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.
