FDA Inspection
H & A Walters Fulfillment Center LLC.H & A Walters Fulfillment Center LLC. – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns H & A Walters Fulfillment Center LLC., with an inspection on March 15, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Joseph F. Owens (FDA Associated Person)
- Lourene S. Phillips (Issuing Officer)
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ID · 680f3870-50a4-436e-9146-fa58c554166d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1082692
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.510Returned dietary supplement - material review, disposition
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.83(b)(1)Reserve sample -container-closure system
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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 |
| January 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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