FDA Inspection
Boehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim Pharmaceuticals, Inc. – FDA Inspection, Jul 28, 2017
Record Details
This FDA Inspection record concerns Boehringer Ingelheim Pharmaceuticals, Inc., with an inspection on July 28, 2017, issued by the New England District Office, covering human drugs.
- Inspection Date
- July 28, 2017
- Product Type
- Human Drugs
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ID · e3b667cd-82de-4b3a-a62c-e7c7a8a04994
Inspection Facts
- Inspection number
- 1019749
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Boehringer Ingelheim Pharmaceuticals, Inc.
19| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2026 | Not classified | New England District Office | |
| September 11, 2025 | VAI | New England District Office | Bioresearch Monitoring: Human Drugs |
| May 2, 2024 | Not classified | New England District Office | |
| September 22, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 12, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Boehringer Ingelheim Pharmaceuticals, Inc.
- FDA Inspection 1334848 - 2026-08-25
- FDA Inspection 1281125 - 2025-09-11
- FDA Inspection 1235545 - 2024-05-02
- FDA Inspection 1219707 - 2023-09-22
- FDA Inspection 1112627 - 2019-12-12
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