FDA Inspection
KVK Tech, Inc.KVK Tech, Inc. – FDA Inspection, Jan 24, 2018
Record Details
This FDA Inspection record concerns KVK Tech, Inc., with an inspection on January 24, 2018, issued by the Philadelphia District Office, covering human drugs.
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ID · 50c64ed4-afd7-4e18-98ed-f197b3da56a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1038700
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| April 16, 2019 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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 1086467 - 2019-04-16
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