1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy — FDA 483 Findings
Inspectors David G. EngThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The flow of components, drug product containers, closures, in-process materials, and drug products though the building is not designed to prevent contamination.
3Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
4Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
5Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
6Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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 in that walls and ceilings are not smooth and/or hard surfaces that are easily cleanable.
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.
