FDA Inspection
Island Kinetics, Inc. d.b.a. CoValence LaboratoriesIsland Kinetics, Inc. d.b.a. CoValence Laboratories – FDA Inspection, Sep 2, 2016
Record Details
This FDA Inspection record concerns Island Kinetics, Inc. d.b.a. CoValence Laboratories, with an inspection on September 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 2, 2016
- Product Type
- Drugs
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ID · a5492738-da2b-479e-99e6-6240394ae78b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984596
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Island Kinetics, Inc. d.b.a. CoValence Laboratories
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2026 | OAI | Denver District Office | Drug Quality Assurance |
| January 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Island Kinetics, Inc. d.b.a. CoValence Laboratories
- FDA Inspection 1299522 - 2026-01-23
- FDA Inspection 1114441 - 2020-01-06
- FDA Inspection 781937 - 2012-05-16
- FDA Inspection 721961 - 2011-04-21
- FDA Inspection 673188 - 2010-06-16
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