FDA Inspection
Nitto Avecia Pharma Services, Inc.Nitto Avecia Pharma Services, Inc. – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Nitto Avecia Pharma Services, Inc., with an inspection on November 2, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · a619f57e-742b-46ad-8f7a-35359416ec20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031579
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of Nitto Avecia Pharma Services, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 22, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 24, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 24, 2019 | Not classified | Los Angeles District Office | New Drug Evaluation |
Other documents for Nitto Avecia Pharma Services, Inc.
- FDA Inspection 1279210 - 2025-07-25
- FDA Inspection 1220658 - 2023-09-22
- FDA Inspection 1116308 - 2020-01-24
- FDA Inspection 1103011 - 2019-09-06
- FDA Inspection 1091017 - 2019-05-24
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