FDA Inspection
Laboratoris FeltorLaboratoris Feltor – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Laboratoris Feltor, with an inspection on September 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b207bfa7-463e-4146-9d65-f23b5ba7e8d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067038
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Laboratoris Feltor
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratoris Feltor
- FDA Inspection 1262694 - 2023-06-15
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