FDA Inspection
Pharmaceutics International, Inc.Pharmaceutics International, Inc. – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Pharmaceutics International, Inc., with an inspection on November 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f3ba1bae-6f2d-49d8-ad30-c59d2fe1ee3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072073
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Pharmaceutics International, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | Not classified | Baltimore District Office | Drug Quality Assurance |
| June 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Pharmaceutics International, Inc.
- FDA Inspection 1307080 - 2026-03-06
- FDA Inspection 1244595 - 2024-06-12
- FDA Inspection 1194409 - 2022-11-14
- FDA Inspection 1155191 - 2021-09-29
- FDA Inspection 1124545 - 2020-07-10
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