FDA Inspection
H & A Walters Fulfillment Center LLC.H & A Walters Fulfillment Center LLC. – FDA Inspection, Jan 20, 2017
Record Details
This FDA Inspection record concerns H & A Walters Fulfillment Center LLC., with an inspection on January 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Lourene S. Phillips (Issuing Officer)
- Tamara J. Henderson (FDA Associated Person)
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ID · 100258c0-04ab-4b84-a12e-c0e509b52a27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998960
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of H & A Walters Fulfillment Center LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2020 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 15, 2019 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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