FDA Inspection
Apothecus Pharmaceutical Corp.Apothecus Pharmaceutical Corp. – FDA Inspection, Apr 30, 2019
Record Details
This FDA Inspection record concerns Apothecus Pharmaceutical Corp., with an inspection on April 30, 2019, issued by the New York District Office, covering human drugs.
View Company Profile
ID · 9b53da5c-8dc1-4c0c-bfe5-de15cb4523ba
Inspection Facts
- Inspection number
- 1087948
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apothecus Pharmaceutical Corp.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | New York District Office | Drug Quality Assurance |
| October 6, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apothecus Pharmaceutical Corp.
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.