FDA Inspection
P&L Developments, LLCP&L Developments, LLC – FDA Inspection, Mar 27, 2009
Record Details
This FDA Inspection record concerns P&L Developments, LLC, with an inspection on March 27, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- P&L Developments, LLC
- Inspection Date
- March 27, 2009
- Product Type
- Drugs
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ID · cbd44c23-952f-426f-82ef-6f2a2d0ed912
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 573151
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.137(b)Storage conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.166(b)Tentative expiration date
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of P&L Developments, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2018 | VAI | 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 |
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