FDA Inspection
Romark Laboratories, L.C.Romark Laboratories, L.C. – FDA Inspection, May 8, 2017
Record Details
This FDA Inspection record concerns Romark Laboratories, L.C., with an inspection on May 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bd7ec163-2739-4503-afbc-8a1593de8813
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010173
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Romark Laboratories, L.C.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 13, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 21, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Romark Laboratories, L.C.
- FDA Inspection 1216528 - 2023-08-23
- FDA Inspection 806976 - 2012-11-13
- FDA Inspection 612055 - 2009-09-21
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