FDA Inspection
Ohm Laboratories Inc.Ohm Laboratories Inc. – FDA Inspection, Feb 5, 2020
Record Details
This FDA Inspection record concerns Ohm Laboratories Inc., with an inspection on February 5, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ohm Laboratories Inc.
- Inspection Date
- February 5, 2020
- Product Type
- Drugs
View Company Profile
ID · 9c572ec5-c92d-4552-8091-736c7f2a2a1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116917
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Ohm Laboratories Inc.
23| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 12, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2023 | Not classified | New Jersey District Office | |
| November 10, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ohm Laboratories Inc.
- FDA Inspection 1254992 - 2024-10-31
- FDA Inspection 1230728 - 2024-01-12
- FDA Inspection 1207376 - 2023-05-16
- FDA Inspection 1192906 - 2022-11-10
- FDA Inspection 1151837 - 2021-08-02
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