KVK-TECH, INC.
FDA inspection history across 2 sites, 2019 to 2022
- 3
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Three Form 483s and one close-out letter, at Newtown, Pennsylvania and NEWTOWN, Pennsylvania.
- 2022The longest 483 on file: 10 observations over 17 pages at NEWTOWN, Pennsylvania.
Cited most
Across all KVK-TECH observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.160General requirements3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.198Complaint files2
The complete KVK-TECH file.
All 4 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
NEWTOWN, Pennsylvania
Two Form 483s · 2021 to 2022 · 18 observations
Latest: Form 483, Jul 8, 2022 →Newtown, Pennsylvania
One close-out letter and one Form 483 · 2019 to 2020 · 7 observations
Latest: Close-out, Feb 11, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-08 | 483 Form 483 | NEWTOWN, Pennsylvania | 10 | $99 |
| 2021-06-11 | 483 Form 483 | NEWTOWN, Pennsylvania | 8 | $99 |
| 2020-02-11 | Close-out Close-out letter | Newtown, Pennsylvania | — | $99 |
| 2019-04-16 | 483 Form 483 | Newtown, Pennsylvania | 7 | $99 |
Investigators on these documents
Jose M. Cayuela (1)Junho Pak (1)Karen A. Briggs (1)Michael R. Klapal (1)Michele Gottshall (1)Monika Borkowska (1)Nicholas Violand (1)Patric C. Klotzbuecher (1)Saleem A. Akhtar (1)Yvesna Blaise (1)
FEI number 3005117563 · most recent document Jul 8, 2022
About KVK-TECH, INC.
How many FDA Form 483s has KVK-TECH, INC. received?
FDA Intel has 3 Form 483s on file for KVK-TECH, INC.; the most recent is dated Jul 8, 2022.
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 Jul 8, 2022, 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 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.160 (General requirements), 3 times.