FDA Inspection
Romark Laboratories, L.C.Romark Laboratories, L.C. – FDA Inspection, Sep 21, 2009
Record Details
This FDA Inspection record concerns Romark Laboratories, L.C., with an inspection on September 21, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Romark Laboratories, L.C.
- Inspection Date
- September 21, 2009
- Product Type
- Drugs
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ID · 299737a1-9e42-4d47-9929-6561e2f2973c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612055
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(2)Interval
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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 |
| May 8, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 13, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Romark Laboratories, L.C.
- FDA Inspection 1216528 - 2023-08-23
- FDA Inspection 1010173 - 2017-05-08
- FDA Inspection 806976 - 2012-11-13
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