FDA Inspection
P&L Developments, LLCP&L Developments, LLC – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns P&L Developments, LLC, with an inspection on September 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e8884596-2ae8-492f-b2c2-dbe2cb6ed465
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067036
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of P&L Developments, LLC
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|---|---|---|---|
| May 15, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 12, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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