Celltex Therapeutics Corporation
FDA inspection history in Sugarland, Texas, 2012
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2012: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter and one Form 483, at Sugarland, Texas.
Cited most
Across all Celltex Therapeutics observations on file
- 21 CFR 211.80(a)General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 1271.370(a)Labeling1
- 21 CFR 211.105(b)Equipment identification1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Celltex Therapeutics 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
Sugarland, Texas
One warning letter and one Form 483 · 2012 · 14 observations
Latest: Warning letter, Sep 24, 2012 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-09-24 | Warning letter Warning letter | Sugarland, Texas | — | $99 |
| 2012-04-27 | 483 Form 483 | Sugarland, Texas | 14 | $99 |
Investigators on these documents
FEI number 3009499974 · most recent document Sep 24, 2012
About Celltex Therapeutics Corporation
How many FDA Form 483s has Celltex Therapeutics Corporation received?
FDA Intel has 1 Form 483 on file for Celltex Therapeutics Corporation; the most recent is dated Apr 27, 2012.
When was Celltex Therapeutics Corporation last inspected by FDA?
The most recent FDA inspection document on file for Celltex Therapeutics Corporation is a Form 483 dated Apr 27, 2012, for the site in Sugarland, Texas.
What did FDA cite at Celltex Therapeutics Corporation?
The regulations cited most in the observations on file for Celltex Therapeutics Corporation are 21 CFR 211.80(a) (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 1271.370(a) (Labeling), 1 time.
Has Celltex Therapeutics Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Celltex Therapeutics Corporation; the most recent is dated Sep 24, 2012.