FDA Inspection
Hit Promo LLCHit Promo LLC – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns Hit Promo LLC, with an inspection on October 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9d78f693-050d-428b-9b8c-216e4c366fdf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221225
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Hit Promo LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 2, 2024 | Not classified | New Jersey District Office | |
| January 17, 2019 | Not classified | New Jersey District Office | |
| June 18, 2014 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hit Promo LLC
- FDA Inspection 1226697 - 2024-01-02
- FDA Inspection 1077308 - 2019-01-17
- FDA Inspection 882604 - 2014-06-18
- FDA Inspection 779017 - 2012-04-30
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