Kaylaan LLC
FDA inspection history in Floral Park, New York, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Floral Park, New York.
Cited most
Across all Kaylaan observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.101(d)Charge-in of components1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.180(e)(1)General requirements1
The complete Kaylaan file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Floral Park, New York
One warning letter and one Form 483 · 2024 · 13 observations
Latest: Warning letter, Aug 19, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-19 | Warning letter Warning letter | Floral Park, New York | — | $99 |
| 2024-03-01 | 483 Form 483 | Floral Park, New York | 13 | $99 |
Investigators on these documents
FEI number 3021091668 · most recent document Aug 19, 2024
About Kaylaan LLC
How many FDA Form 483s has Kaylaan LLC received?
FDA Intel has 1 Form 483 on file for Kaylaan LLC; the most recent is dated Mar 1, 2024.
When was Kaylaan LLC last inspected by FDA?
The most recent FDA inspection document on file for Kaylaan LLC is a Form 483 dated Mar 1, 2024, for the site in Floral Park, New York.
What did FDA cite at Kaylaan LLC?
The regulations cited most in the observations on file for Kaylaan LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.101(d) (Charge-in of components), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Kaylaan LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kaylaan LLC; the most recent is dated Aug 19, 2024.