FDA Inspection
Pharmaceutics International, Inc.Pharmaceutics International, Inc. – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns Pharmaceutics International, Inc., with an inspection on October 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 210de1ab-41c0-407d-a223-367de4d1e793
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1030024
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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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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