Chemolee Lab Corporation
FDA inspection history in Irving, Texas, 2015 to 2017
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2015: one Form 483; 2016: one warning letter; 2017: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One Form 483, one warning letter and one close-out letter, at Irving, Texas.
Cited most
Across all Chemolee Lab observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.160(b)General requirements1
The complete Chemolee Lab 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
Irving, Texas
One close-out letter, one warning letter and one Form 483 · 2015 to 2017 · 13 observations
Latest: Close-out, Dec 14, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-14 | Close-out Close-out letter | Irving, Texas | — | $99 |
| 2016-02-23 | Warning letter Warning letter | Irving, Texas | — | $99 |
| 2015-02-13 | 483 Form 483 | Irving, Texas | 13 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Elisa M. Fleming (1)Lisa R. Jennings (1)
FEI number 1642813 · most recent document Dec 14, 2017
About Chemolee Lab Corporation
How many FDA Form 483s has Chemolee Lab Corporation received?
FDA Intel has 1 Form 483 on file for Chemolee Lab Corporation; the most recent is dated Feb 13, 2015.
When was Chemolee Lab Corporation last inspected by FDA?
The most recent FDA inspection document on file for Chemolee Lab Corporation is a Form 483 dated Feb 13, 2015, for the site in Irving, Texas.
What did FDA cite at Chemolee Lab Corporation?
The regulations cited most in the observations on file for Chemolee Lab Corporation are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.105(a) (Equipment identification), 1 time.
Has Chemolee Lab Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Chemolee Lab Corporation; the most recent is dated Feb 23, 2016.