FDA Inspection
Maco Productions S.A.S.Maco Productions S.A.S. – FDA Inspection, Sep 12, 2017
Record Details
This FDA Inspection record concerns Maco Productions S.A.S., with an inspection on September 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 480fe004-3ea6-4ff5-afb7-96a38a622b08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025023
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Maco Productions S.A.S.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2024 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| April 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Maco Productions S.A.S.
- FDA Inspection 1226824 - 2024-01-11
- FDA Inspection 881929 - 2014-04-17
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