FDA Inspection
Digestive Care IncDigestive Care Inc – FDA Inspection, Jul 27, 2018
Record Details
This FDA Inspection record concerns Digestive Care Inc, with an inspection on July 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fe1857bd-34f4-4e32-8337-c06fdaf1af33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060191
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Digestive Care Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| June 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Digestive Care Inc
- FDA Inspection 1315896 - 2026-05-05
- FDA Inspection 1208822 - 2023-06-27
- FDA Inspection 942797 - 2015-09-25
- FDA Inspection 771288 - 2012-03-02
- FDA Inspection 666900 - 2010-06-11
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