FDA Inspection
Advanced Pharmaceutical Technology Inc.Advanced Pharmaceutical Technology Inc. – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns Advanced Pharmaceutical Technology Inc., with an inspection on September 27, 2019, issued by the New York District Office, covering human drugs.
- Inspection Date
- September 27, 2019
- Product Type
- Human Drugs
View Company Profile
ID · b3c8cc64-c241-44bc-b851-e23f4a6228fa
Inspection Facts
- Inspection number
- 1102933
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Pharmaceutical Technology Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Pharmaceutical Technology Inc.
- FDA Inspection 1245209 - 2024-08-01
- FDA Inspection 1149530 - 2021-08-23
- FDA Inspection 887407 - 2014-07-14
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.