Kings Park Slope Inc.
FDA inspection history in Brooklyn, New York, 2014 to 2019
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2016: one Form 483; 2018: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Three Form 483s, one warning letter and one close-out letter, at Brooklyn, New York.
- 2016The longest 483 on file: 9 observations over 6 pages at Brooklyn, New York.
Cited most
Across all Kings Park Slope observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features5
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Kings Park Slope file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Brooklyn, New York
Three Form 483s, one close-out letter and one warning letter · 2014 to 2019 · 21 observations
Latest: Close-out, Nov 15, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-15 | Close-out Close-out letter | Brooklyn, New York | — | $99 |
| 2018-09-14 | 483 Form 483 | Brooklyn, New York | 4 | $99 |
| 2016-04-22 | 483 Form 483 | Brooklyn, New York | 9 | $99 |
| 2015-03-27 | Warning letter Warning letter | Brooklyn, New York | — | $99 |
| 2014-03-14 | 483 Form 483 | Brooklyn, New York | 8 | $99 |
Investigators on these documents
Charisse K. Green (1)James A. Liubicich (1)Mindy M. Chou (1)Rachael Moliver (1)Robert C. Horan (1)
FEI number 3007174596 · most recent document Nov 15, 2019
About Kings Park Slope Inc.
How many FDA Form 483s has Kings Park Slope Inc. received?
FDA Intel has 3 Form 483s on file for Kings Park Slope Inc.; the most recent is dated Sep 14, 2018.
When was Kings Park Slope Inc. last inspected by FDA?
The most recent FDA inspection document on file for Kings Park Slope Inc. is a Form 483 dated Sep 14, 2018, for the site in Brooklyn, New York.
What did FDA cite at Kings Park Slope Inc.?
The regulations cited most in the observations on file for Kings Park Slope Inc. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 5 times; FDCA 501(a)(2)(A) (Insanitary conditions), 3 times.
Has Kings Park Slope Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kings Park Slope Inc.; the most recent is dated Mar 27, 2015.