FDA Inspection
Pharmaceutics International IncPharmaceutics International Inc – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns Pharmaceutics International Inc, with an inspection on March 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 937b2562-f2e2-49c9-b309-a6fae299a5d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011664
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Pharmaceutics International Inc
13| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2024 | VAI | Baltimore District Office | Drug Quality Assurance |
| November 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
Other documents for Pharmaceutics International Inc
- FDA Inspection 1251950 - 2024-12-06
- FDA Inspection 1194130 - 2022-11-14
- FDA Inspection 1155001 - 2021-09-29
- FDA Inspection 1124614 - 2020-07-10
- FDA Inspection 1071297 - 2018-11-09
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