FDA Inspection
Lusomedicamenta Sociedade Tecnica Farmaceutica S.ALusomedicamenta Sociedade Tecnica Farmaceutica S.A – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns Lusomedicamenta Sociedade Tecnica Farmaceutica S.A, with an inspection on September 27, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- September 27, 2019
- Product Type
- Veterinary
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ID · f0d6465c-8d3b-4fc1-b94e-8156f1cece6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102946
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2016 | NAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
- FDA Inspection 1269402 - 2024-10-18
- FDA Inspection 969956 - 2016-04-15
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