FDA Inspection
A&Z Pharmaceutical IncA&Z Pharmaceutical Inc – FDA Inspection, Nov 22, 2017
Record Details
This FDA Inspection record concerns A&Z Pharmaceutical Inc, with an inspection on November 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Alice S. Tsao (FDA Associated Person)
- Jay T. Wong (Issuing Officer)
View Company Profile
ID · 9c367c2a-267e-4712-8943-b7e37fb8e0b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034103
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.208Salvaging and return to marketplace
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of A&Z Pharmaceutical Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | VAI | New York District Office | Drug Quality Assurance |
| April 17, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 27, 2022 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 31, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for A&Z Pharmaceutical Inc
- FDA Inspection 1278897 - 2025-09-26
- FDA Inspection 1234123 - 2024-04-17
- FDA Inspection 1174491 - 2022-06-27
- FDA Inspection 921710 - 2015-03-31
- FDA Inspection 883147 - 2014-06-03
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.