FDA Inspection
Nitto Avecia Pharma Services, Inc.Nitto Avecia Pharma Services, Inc. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Nitto Avecia Pharma Services, Inc., with an inspection on May 24, 2019, issued by the Los Angeles District Office, covering human drugs.
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ID · 91fd31d7-fb39-4228-b9b5-f3b3f3c4fb1c
Inspection Facts
- Inspection number
- 1091017
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| November 2, 2017 | VAI | Los Angeles District Office | Generic 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 1031579 - 2017-11-02
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