FDA Inspection
Nationwide Laboratories, LLCNationwide Laboratories, LLC – FDA Inspection, Nov 27, 2018
Record Details
This FDA Inspection record concerns Nationwide Laboratories, LLC, with an inspection on November 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ef042152-39ba-4172-bae5-ecaa352e26f7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1072711
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 310.305(a)Failure to develop written procedures
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Other FDA inspections of Nationwide Laboratories, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2016 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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