FDA Inspection
Reliant Holding, Ltd.Reliant Holding, Ltd. – FDA Inspection, Jun 21, 2016
Record Details
This FDA Inspection record concerns Reliant Holding, Ltd., with an inspection on June 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Reliant Holding, Ltd.
- Inspection Date
- June 21, 2016
- Product Type
- Drugs
View Company Profile
ID · 8fb4d1d7-01c6-421c-98a1-70a54cabd4a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974968
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Reliant Holding, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2018 | Not classified | Denver District Office |
Other documents for Reliant Holding, Ltd.
- FDA Inspection 1073716 - 2018-12-05
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