1Environmental monitoring
Sporicidal agents are not used in your facility's cleanrooms and/or ISO 5 area.
Inspection Record
Maimonides Medical Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hands, wrists, legs, hair, or mouth.
6Environmental monitoring
Sinks or drains are present in the cleanroom where the ISO 5 area is located.
7Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area aseptic processing areas are not sterile.
8Contamination control
Non-microbial contamination was observed in your production area.
9Contamination control
Beta-lactam drugs were produced without providing adequate containment, segregation, ancVor cleaning of work surfaces, utensils, ancVor personnel to prevent cross-contamination.
10Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.Specifically, unidirectional airflow was not verified under operational conditions.
11Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.
12Equipment and facility
Inadequate pressure differentials between rougher quality air rooms and lower quality air rooms were observed.
13Aseptic processing and sterility assurance
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic production without adequate product evaluation and remedial action.
14Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
15Equipment and facility
The facility is designed and/or operated in a way that permits poor flow of personnel or materials.
16Other quality system
The ISO 5 classified area is located within a non-dassified room (segregated production area).
About this record
Extracted automatically from the document US FDA published on 2019-11-05. 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.
