FDA Inspection
FICOSOTA LTDFICOSOTA LTD – FDA Inspection, Sep 5, 2019
Record Details
This FDA Inspection record concerns FICOSOTA LTD, with an inspection on September 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 7d6e5b9a-2469-4b1b-914a-147ec9e6db4d
Inspection Facts
- Inspection number
- 1101635
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
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