FDA Inspection
SHL Pharma LLCSHL Pharma LLC – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns SHL Pharma LLC, with an inspection on July 11, 2019, issued by the Florida District Office, covering human drugs.
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ID · 98658663-2a12-4078-b1fa-b1154cb46d43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095867
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of SHL Pharma LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SHL Pharma LLC
- FDA Inspection 1280537 - 2025-08-28
- FDA Inspection 1081765 - 2019-01-29
- FDA Inspection 953453 - 2015-12-14
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