FDA Inspection
Laboratorios Zepol S.A.Laboratorios Zepol S.A. – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Laboratorios Zepol S.A., with an inspection on November 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c5ccb085-de48-420d-83ee-d1598b01c619
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223082
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.192Written record of investigation incomplete
Showing 10 of 12 citations.
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Other FDA inspections of Laboratorios Zepol S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorios Zepol S.A.
- FDA Inspection 1204690 - 2023-03-09
- FDA Inspection 1008927 - 2017-03-29
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