FDA Inspection
Omega & Delta Co., Inc.Omega & Delta Co., Inc. – FDA Inspection, Dec 16, 2015
Record Details
This FDA Inspection record concerns Omega & Delta Co., Inc., with an inspection on December 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Omega & Delta Co., Inc.
- Inspection Date
- December 16, 2015
- Product Type
- Drugs
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ID · 362ef15b-b72c-47d4-a2bb-5952f445ad5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966974
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Omega & Delta Co., Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | Not classified | San Juan District Office | Drug Quality Assurance |
| October 23, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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