FDA Inspection
Alps Pharmaceutical Industrial Co., Ltd.Alps Pharmaceutical Industrial Co., Ltd. – FDA Inspection, Jan 27, 2017
Record Details
This FDA Inspection record concerns Alps Pharmaceutical Industrial Co., Ltd., with an inspection on January 27, 2017, issued by the Office of Inspections and Investigations, covering animal drugs & feeds.
- Inspection Date
- January 27, 2017
- Product Type
- Animal Drugs & Feeds
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ID · f43e26cf-fac7-412b-ba04-aff533067375
Inspection Facts
- Inspection number
- 1004236
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.170(a)Reserve sample quantity - active ingredients only
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Other FDA inspections of Alps Pharmaceutical Industrial Co., Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | Not classified | Office of Inspections and Investigations | |
| May 26, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 19, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Alps Pharmaceutical Industrial Co., Ltd.
- FDA Inspection 1290398 - 2025-10-17
- FDA Inspection 1208000 - 2023-05-26
- FDA Inspection 1087824 - 2019-04-05
- FDA Inspection 1005472 - 2017-02-03
- FDA Inspection 937950 - 2015-06-19
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