FDA Inspection
Nationwide Laboratories, LLCNationwide Laboratories, LLC – FDA Inspection, Aug 19, 2016
Record Details
This FDA Inspection record concerns Nationwide Laboratories, LLC, with an inspection on August 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Nationwide Laboratories, LLC
- Inspection Date
- August 19, 2016
- Product Type
- Drugs
View Company Profile
ID · 34624d0c-efa1-4b92-b10f-0a531a5cc8b2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 988951
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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Other FDA inspections of Nationwide Laboratories, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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