Kings Park Slope Inc.
Form 483 issued April 22, 2016 · Brooklyn, New York
- Inspection
- Apr 4 – Apr 22, 2016
- Investigators
- Mindy M. Chou· Robert C. Horan
- Observations
- 9
- Pages
- 6
- FEI number
- 3007174596
In short: On April 22, 2016, FDA issued a Form 483 with 9 observations to Kings Park Slope Inc. in Brooklyn, New York (FEI 3007174596) after an inspection that ran Apr 4 – Apr 22, 2016. The investigators were Mindy M. Chou and Robert C. Horan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Written records are not made of investigations…
- 04
The separate or defined areas necessary to prevent contamination…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) 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 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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.?
Mindy M. Chou and Robert C. Horan are named on this Form 483, for the inspection of Apr 4 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was Kings Park Slope Inc. inspected by FDA?
The inspection ran Apr 4 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
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.