FDA Inspection
Empack Spraytech Inc.Empack Spraytech Inc. – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Empack Spraytech Inc., with an inspection on November 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 87b484da-b5d4-44f7-bac9-932bd790419a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221867
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Empack Spraytech Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2018 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 3, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 3, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Empack Spraytech Inc.
- FDA Inspection 1059402 - 2018-05-25
- FDA Inspection 1001616 - 2017-02-03
- FDA Inspection 967935 - 2016-03-03
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