FDA Inspection
Pharmaceutics International IncPharmaceutics 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.
View Company Profile
ID · ef1ea56b-657d-4c27-bcb6-2acd36b96c8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071297
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 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 211.42(c)(4)In-Process Material Area
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
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 16, 2017 | VAI | Center for Drug Evaluation and Research | Generic 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 1031480 - 2017-11-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.