FDA Inspection
JHS SVENDGAARD LABORATORIES LIMITEDJHS SVENDGAARD LABORATORIES LIMITED – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns JHS SVENDGAARD LABORATORIES LIMITED, with an inspection on August 27, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 175bf5cc-12e7-46fb-ac4b-97d9a74028ad
Inspection Facts
- Inspection number
- 1333456
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of JHS SVENDGAARD LABORATORIES LIMITED
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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