Kiltex Corporation
FDA inspection history in Akron, Ohio, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Akron, Ohio.
Cited most
Across all Kiltex observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.50(a)(3)Purchasing controls1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.90(a)Nonconforming product1
The complete Kiltex file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Akron, Ohio
One Form 483 · 2015 · 5 observations
Latest: Form 483, May 19, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-05-19 | 483 Form 483 | Akron, Ohio | 5 | $99 |
Investigators on these documents
FEI number 1527493 · most recent document May 19, 2015
About Kiltex Corporation
How many FDA Form 483s has Kiltex Corporation received?
FDA Intel has 1 Form 483 on file for Kiltex Corporation; the most recent is dated May 19, 2015.
When was Kiltex Corporation last inspected by FDA?
The most recent FDA inspection document on file for Kiltex Corporation is a Form 483 dated May 19, 2015, for the site in Akron, Ohio.
What did FDA cite at Kiltex Corporation?
The regulations cited most in the observations on file for Kiltex Corporation are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.50(a)(3) (Purchasing controls), 1 time.