FDA Inspection
Ohm Laboratories Inc.Ohm Laboratories Inc. – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns Ohm Laboratories Inc., with an inspection on August 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · a636b028-97e2-409c-9849-68ccc99def41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062424
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(b)Representative Samples
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.