Kings Park Slope Inc.
Form 483 issued September 14, 2018 · Brooklyn, New York
- Inspection
- Aug 21 – Sep 14, 2018
- Investigator
- Rachael Moliver
- Observations
- 4
- Pages
- 3
- FEI number
- 3007174596
In short: On September 14, 2018, FDA issued a Form 483 with 4 observations to Kings Park Slope Inc. in Brooklyn, New York (FEI 3007174596) after an inspection that ran Aug 21 – Sep 14, 2018. The investigator was Rachael Moliver. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
The use ofsporicidal agents in the ISO 5 classified aseptic…
- 02FDCA 501(a)(2)(A)
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into a higher classified area. Inadequate…
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
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 firmKings Park Slope Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kings Park Slope Inc.?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Kings Park Slope Inc.?
Rachael Moliver is named on this Form 483, for the inspection of Aug 21 – Sep 14, 2018. Each investigator has a profile showing what they cite most.
When was Kings Park Slope Inc. inspected by FDA?
The inspection ran Aug 21 – Sep 14, 2018, and the Form 483 is dated September 14, 2018.
How do I get the full Form 483 for Kings Park Slope Inc.?
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.