FDA Inspection
Leading Pharma, LLCLeading Pharma, LLC – FDA Inspection, Apr 14, 2017
Record Details
This FDA Inspection record concerns Leading Pharma, LLC, with an inspection on April 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · efbfdb8f-5704-4965-b98b-7af22956981e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010916
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
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Other FDA inspections of Leading Pharma, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2024 | VAI | New Jersey District Office | Drug Quality Assurance |
| August 11, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 31, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Leading Pharma, LLC
- FDA Inspection 1251315 - 2024-10-21
- FDA Inspection 1129205 - 2020-08-11
- FDA Inspection 1079111 - 2019-01-31
- FDA Inspection 1067964 - 2018-08-31
- FDA Inspection 965261 - 2016-03-10
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