1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Maplerose Enterprises LLC dba Pencol Pharmacy — FDA 483 Findings
Inspectors Michael E. Maselli · Zachery L. Miller · Zachary A. BogoradThe 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
Protective apparel is not worn as necessary to protect drug products from c ontamination.
3Equipment and facility
Routine calibration, inspection and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to r elease.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting room and equipment to produce aseptic conditions.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
8Equipment and facility
Buildings used in the processing of a drug product are not maintained in a good state of repair.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
10Material and supplier control
Each lot of a component, drug product containers and closures liable to objectionable m i crobiological con tamination is deficiently subjected to microbiological tests before use.
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.
