FDA Inspection
KVK Tech, Inc.KVK Tech, Inc. – FDA Inspection, Apr 16, 2019
Record Details
This FDA Inspection record concerns KVK Tech, Inc., with an inspection on April 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Michael R. Klapal (FDA Associated Person)
- Nicholas A. Violand (FDA Associated Person)
- Patric C. Klotzbuecher (Issuing Officer)
- Yvesna C. Blaise (Issuing Officer)
View Company Profile
ID · 3516aa77-76ef-46bc-9a8f-f906717f4eb0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1086467
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(3)Determination not to conduct investigation of complaint
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of KVK Tech, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| March 14, 2025 | OAI | Philadelphia District Office | Drug Quality Assurance |
| October 21, 2024 | Not classified | Philadelphia District Office | |
| July 8, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for KVK Tech, Inc.
- FDA Inspection 1329488 - 2026-08-04
- FDA Inspection 1233334 - 2025-03-14
- FDA Inspection 1229759 - 2024-10-21
- FDA Inspection 1175552 - 2022-07-08
- FDA Inspection 1066940 - 2018-09-21
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