FDA Inspection
Pharmaceutics International IncPharmaceutics International Inc – FDA Inspection, Nov 16, 2017
Record Details
This FDA Inspection record concerns Pharmaceutics International Inc, with an inspection on November 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c3063d1f-4eb3-45a3-bd4f-fce372d3b590
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031480
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.63Equipment Design, Size and Location
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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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