FDA Inspection
Multaler Et Cie S.A.S.Multaler Et Cie S.A.S. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Multaler Et Cie S.A.S., with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6f6ab042-5c86-46da-abfa-6946478b6155
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026086
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Multaler Et Cie S.A.S.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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