FDA Inspection
We Pack It All LLCWe Pack It All LLC – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns We Pack It All LLC, with an inspection on November 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 023c27bc-4ef1-4e31-b6a0-63623fe8ab11
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1070631
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of We Pack It All LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 10, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| October 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2017 | Not classified | Los Angeles District Office | |
| December 21, 2010 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for We Pack It All LLC
- FDA Inspection 1140505 - 2021-03-19
- FDA Inspection 1037718 - 2018-01-10
- FDA Inspection 1029322 - 2017-10-20
- FDA Inspection 1024815 - 2017-08-11
- FDA Inspection 719871 - 2010-12-21
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