# FDA 483 - Maimonides Medical Center - Pharmacy - July 29, 2019

Source: https://www.keypedia.com/records/483/maimonides-medical-center-pharmacy/6eb2e665-8c86-4be8-91dd-3d2e05ddde7f

> FDA 483 for Maimonides Medical Center - Pharmacy on July 29, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maimonides Medical Center - Pharmacy
- Inspection Date: 2019-07-29
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies in aseptic processing and facility control. Multiple instances of actionable microbial contamination were found in ISO Class 5 and ISO Class 7 areas, including Penicillium, Gram-positive rods, Micrococcus, Bacillus, and Yeasts. Non-microbial contamination was widespread, with observations of damaged, dirty, and discolored HEPA filters, cracks in hood glass shields, and structural damage to floors, walls, ceilings, and doors in cleanrooms. A dirty sticky mat was also noted.

Hazardous and beta-lactam drugs were produced without adequate containment or segregation, leading to potential cross-contamination. Personnel practices were deficient, with observations of gloved hands touching non-ISO 5 surfaces without re-sanitization, exposed body parts during aseptic processing, and the use of non-sterile gloves.

Facility design and operation issues included unclassified areas surrounding ISO 5 hoods in satellite pharmacies, a door that did not close completely, inadequate storage space in the hazardous cleanroom, and a dirty, blocked air return. Sinks were present in cleanrooms. Non-sterile disinfecting agents and wipes were used in ISO 5 areas, and sporicidal agents were not utilized. Equipment and supplies were not disinfected prior to entering aseptic processing areas.

Cleaning and disinfection procedures were inadequate; TPN compounder equipment was not removed for routine cleaning, IV (b)(4) were not cleaned throughout the day, and cleaning logs showed

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## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-a-moliver/6130c1d8-9867-4da5-b113-1bbaf0ae9c79)

Company: https://www.keypedia.com/companies/maimonides-medical-center-pharmacy/61ebefae-a1ee-4667-9df1-6b5a51989224

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d