FDA Inspection
JHS SVENDGAARD LABORATORIES LIMITEDJHS SVENDGAARD LABORATORIES LIMITED – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns JHS SVENDGAARD LABORATORIES LIMITED, with an inspection on August 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · ee961a66-f3a0-41fe-9f37-864bd0288649
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1100282
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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