KVK-Tech, Inc.
FDA inspection history in Newtown, Pennsylvania, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Newtown, Pennsylvania.
Cited most
Across all KVK-Tech observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.188Batch production and control records1
The complete KVK-Tech file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Newtown, Pennsylvania
One Form 483 · 2020 · 11 observations
Latest: Form 483, Mar 13, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-13 | 483 Form 483 | Newtown, Pennsylvania | 11 | $99 |
Investigators on these documents
FEI number 3013676321 · most recent document Mar 13, 2020
About KVK-Tech, Inc.
How many FDA Form 483s has KVK-Tech, Inc. received?
FDA Intel has 1 Form 483 on file for KVK-Tech, Inc.; the most recent is dated Mar 13, 2020.
When was KVK-Tech, Inc. last inspected by FDA?
The most recent FDA inspection document on file for KVK-Tech, Inc. is a Form 483 dated Mar 13, 2020, for the site in Newtown, Pennsylvania.
What did FDA cite at KVK-Tech, Inc.?
The regulations cited most in the observations on file for KVK-Tech, Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.