Kings Park Slope Inc.
Form 483 issued March 14, 2014 · Brooklyn, New York
- Inspection
- Mar 4 – Mar 14, 2014
- Investigators
- Charisse K. Green· James A. Liubicich
- Observations
- 8
- Pages
- 3
- FEI number
- 3007174596
In short: On March 14, 2014, FDA issued a Form 483 with 8 observations to Kings Park Slope Inc. in Brooklyn, New York (FEI 3007174596) after an inspection that ran Mar 4 – Mar 14, 2014. The investigators were Charisse K. Green and James A. Liubicich. 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 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish an adequate system for maintaining equipment used to…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Your firm failed to establish an adequate system for monitoring environmental conditions…
- 04
Your finn failed to establish an adequate system for cleaning and disinfecting the room and equipment…
This inspection in context
Charisse K. Green
5 documents · 2005–2015
Cites 123.6 (hazard analysis and hazard analysis critical control point (haccp) plan) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kings Park Slope Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Kings Park Slope Inc.?
Charisse K. Green and James A. Liubicich are named on this Form 483, for the inspection of Mar 4 – Mar 14, 2014. Each investigator has a profile showing what they cite most.
When was Kings Park Slope Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 14, 2014, and the Form 483 is dated March 14, 2014.
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.