FDA Inspection
Apotheca, Inc.Apotheca, Inc. – FDA Inspection, Oct 11, 2017
Record Details
This FDA Inspection record concerns Apotheca, Inc., with an inspection on October 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 85ff1721-c4b2-47af-b8e3-f86b34bb36f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028450
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.166(a)Lack of written stability program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apotheca, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 3, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotheca, Inc.
- FDA Inspection 1259320 - 2025-01-08
- FDA Inspection 951427 - 2015-10-22
- FDA Inspection 749026 - 2011-10-03
- FDA Inspection 677384 - 2010-08-23
- FDA Inspection 561460 - 2009-01-29
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.