FDA Inspection
PI Pharma IncPI Pharma Inc – FDA Inspection, Aug 22, 2018
Record Details
This FDA Inspection record concerns PI Pharma Inc, with an inspection on August 22, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · b7019783-1a5f-4736-9294-f7e3b58334d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063032
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.325(b)(2)Laboratory methodology followed
- 21 CFR 111.15(d)(2)Pest control measures
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.260(l)(3)Batch record - approved, released, rejected; batch
- 21 CFR 111.120(c)Quality control operations - material review, disposition decision
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Other FDA inspections of PI Pharma Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 15, 2022 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 11, 2015 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 19, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PI Pharma Inc
- FDA Inspection 1203470 - 2023-04-11
- FDA Inspection 1162807 - 2022-02-15
- FDA Inspection 941430 - 2015-09-11
- FDA Inspection 866677 - 2014-02-19
- FDA Inspection 816450 - 2013-02-22
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