FDA Inspection
Apothecus Pharmaceutical Corp.Apothecus Pharmaceutical Corp. – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns Apothecus Pharmaceutical Corp., with an inspection on November 15, 2024, issued by the New York District Office, covering human drugs.
View Company Profile
ID · 868bb9e6-4b96-432d-8cbb-7400baa9c18d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1251530
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 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 |
|---|---|---|---|
| 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 |
| April 30, 2019 | Not classified | New York District Office | 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.