FDA Inspection
NOVA LABORATORIES LIMITEDNOVA LABORATORIES LIMITED – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns NOVA LABORATORIES LIMITED, with an inspection on September 18, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 76a5a983-d14a-47b9-8950-7c350d4c700b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336522
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
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Other FDA inspections of NOVA LABORATORIES LIMITED
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 12, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for NOVA LABORATORIES LIMITED
- FDA Inspection 1278227 - 2025-07-10
- FDA Inspection 1247224 - 2024-08-23
- FDA Inspection 1082524 - 2019-03-12
- FDA Inspection 1089880 - 2019-02-28
- FDA Inspection 1054742 - 2018-05-11
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