FDA Inspection
Infomed Fluids SRLInfomed Fluids SRL – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Infomed Fluids SRL, with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Doan N. Singh (Issuing Officer)
- Meisha R. Sampson (Issuing Officer)
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ID · a7c3f5ea-f1c8-4304-bf4b-1dab5c6fbc72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007433
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Infomed Fluids SRL
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Infomed Fluids SRL
- FDA Inspection 1237913 - 2023-04-07
- FDA Inspection 1128810 - 2018-09-28
- FDA Inspection 914166 - 2015-01-20
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