# FDA 483 - Maimonides Medical Center - Pharmacy - March 09, 2023

Source: https://www.globalkeysolutions.net/records/483/maimonides-medical-center-pharmacy/9eba8d6d-3d4e-4f44-9fc1-825031e12d59

> FDA 483 for Maimonides Medical Center - Pharmacy on March 09, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Maimonides Medical Center - Pharmacy
- Inspection Date: 2023-03-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Maimonides Medical Center - Pharmacy in Brooklyn, NY, was cited for significant deficiencies in its sterile drug production areas. The inspection revealed inadequate facility design and environmental controls in both the Emergency Department and Medical Intensive Care Unit satellite pharmacies. These issues, including poor air quality, contamination risks around ISO 5 laminar flow hoods, and improper cleanroom practices, indicate a high potential for contamination of sterile drug products.

## Related Documents

- [483 - 2019-07-29](https://www.globalkeysolutions.net/records/483/maimonides-medical-center-pharmacy/6eb2e665-8c86-4be8-91dd-3d2e05ddde7f)
- [483 - 2023-03-09](https://www.globalkeysolutions.net/records/483/maimonides-medical-center-pharmacy/5f6b8a4e-5c70-45f2-b20d-15a6baf4eb3b)
- [STATE_REFERRAL_LETTER - 2023-02-14](https://www.globalkeysolutions.net/records/state_referral_letter/maimonides-medical-center-pharmacy/b7c004b9-ceb2-4714-9f9d-038c9534a323)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)
- [Investigator](https://www.globalkeysolutions.net/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961