1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Maple Rose Enterprises, Inc, dba Pencol Pharmacy — FDA 483 Findings
Inspectors Zachary A Bogorad · Zachery L MillerThe 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 cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Equipment and facility
Routine calibration, inspection and checking of mechanical and electronic equipment is not perfo1med according to a written program designed to assme proper perfo1mance.
4Aseptic 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.
5Material and supplier control
Each lot of a component, drug product containers and closures liable to objectionable microbiological tests before use.
6Quality unit oversight
The establishment of laboratory contrnl mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
7Equipment and facility
Buildings used in the processing of a dru g product are not maintained in a good state of repair.
8Laboratory and QC controls
Testing and release of drug product for distribution do not include appropiate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredients p rior to release.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
10Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
