Maimonides Medical Center - Pharmacy
Form 483 issued July 29, 2019 · Brooklyn, New York
- Inspection
- Jul 8 – Jul 29, 2019
- Investigator
- Rachael Moliver
- Observations
- 16
- Pages
- 9
- FEI number
- 3015468054
In short: On July 29, 2019, FDA issued a Form 483 with 16 observations to Maimonides Medical Center - Pharmacy in Brooklyn, New York (FEI 3015468054) after an inspection that ran Jul 8 – Jul 29, 2019. The investigator was Rachael Moliver. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 16 of 16 observations.
Most cited: 21 CFR 211.42 (8×) · 211.113 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic…
- 02
Non-microbial contamination was observed…
- 03
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 04
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
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.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maimonides Medical Center - Pharmacy?
FDA listed 16 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Maimonides Medical Center - Pharmacy?
Rachael Moliver is named on this Form 483, for the inspection of Jul 8 – Jul 29, 2019. Each investigator has a profile showing what they cite most.
When was Maimonides Medical Center - Pharmacy inspected by FDA?
The inspection ran Jul 8 – Jul 29, 2019, and the Form 483 is dated July 29, 2019.
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.