Elite Laboratories Inc
FDA inspection history in Northvale, New Jersey, 2016 to 2017
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2016: one warning letter and one Form 483; 2017: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One warning letter, one Form 483 and one close-out letter, at Northvale, New Jersey.
Cited most
Across all Elite Laboratories observations on file
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Elite Laboratories file.
All 3 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
Northvale, New Jersey
One close-out letter, one warning letter and one Form 483 · 2016 to 2017 · 9 observations
Latest: Close-out, Dec 15, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-15 | Close-out Close-out letter | Northvale, New Jersey | — | $99 |
| 2016-08-25 | Warning letter Warning letter | Northvale, New Jersey | — | $99 |
| 2016-02-02 | 483 Form 483 | Northvale, New Jersey | 9 | $99 |
Investigators on these documents
Jose M. Cayuela (1)Liatte Krueger (1)Melissa T. Roy (1)Nancy F. Scheraga (1)
FEI number 3002644678 · most recent document Dec 15, 2017
About Elite Laboratories Inc
How many FDA Form 483s has Elite Laboratories Inc received?
FDA Intel has 1 Form 483 on file for Elite Laboratories Inc; the most recent is dated Feb 2, 2016.
When was Elite Laboratories Inc last inspected by FDA?
The most recent FDA inspection document on file for Elite Laboratories Inc is a Form 483 dated Feb 2, 2016, for the site in Northvale, New Jersey.
What did FDA cite at Elite Laboratories Inc?
The regulations cited most in the observations on file for Elite Laboratories Inc are 21 CFR 314.80 (Postmarketing reporting of adverse drug experiences), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.160 (General requirements), 1 time.
Has Elite Laboratories Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Elite Laboratories Inc; the most recent is dated Aug 25, 2016.