Maimonides Medical Center - Pharmacy
Form 483 issued March 9, 2023 · Brooklyn, New York
- Inspection
- Feb 14 – Mar 9, 2023
- Investigators
- Edmund F. Mrak· Karishma G. Gopaul· Victoria Spivak
- Observations
- 2
- Pages
- 4
- FEI number
- 3015468054
In short: On March 9, 2023, FDA issued a Form 483 with 2 observations to Maimonides Medical Center - Pharmacy in Brooklyn, New York (FEI 3015468054) after an inspection that ran Feb 14 – Mar 9, 2023. The investigators were Edmund F. Mrak, Karishma G. Gopaul and Victoria Spivak.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 02FDCA 501(a)(2)(A)
Sinks or drains were present in the cleamoom where the ISO 5 classified aseptic…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmMaimonides Medical Center - Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Maimonides Medical Center - Pharmacy?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Maimonides Medical Center - Pharmacy?
Edmund F. Mrak, Karishma G. Gopaul and Victoria Spivak are named on this Form 483, for the inspection of Feb 14 – Mar 9, 2023. Each investigator has a profile showing what they cite most.
When was Maimonides Medical Center - Pharmacy inspected by FDA?
The inspection ran Feb 14 – Mar 9, 2023, and the Form 483 is dated March 9, 2023.
How do I get the full Form 483 for Maimonides Medical Center - Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.