1Process validation
There are no written procedures for production and process controls designed to assure that the drug pro ducts have the identity, strength, quality, and purity they purport or are represented to possess.
Inspection Record
ImprimisRx Pharmacy, LLC — FDA 483 Findings
Inspectors Gayle S Lawson · Lisa B OrrThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing a nd processing operations.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is no t appropriate for the duties they perform.
4Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
5Quality unit oversight
Adequate lab facilities for testing and approval or rejection of components, drug product containers and drug products are not available to the quality control unit.
6Quality unit oversight
Approved components, drug product containers and closures are not retested or reexamined as ap propriate for identity, strength, quality and purity after storage for long periods with subsequent app roval or rejection by the quality control unit.
7Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
8Stability and storage
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
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.
