FDA Inspection
Atlantis Laboratories, IncAtlantis Laboratories, Inc – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns Atlantis Laboratories, Inc, with an inspection on July 24, 2026, issued by the Dallas District Office, covering human drugs.
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ID · ae71dc8e-652a-4ec8-83a5-34dc74789a06
Inspection Facts
- Inspection number
- 1328476
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued, view the record
FDA Citations
7- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Atlantis Laboratories, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2025 | Not classified | Dallas District Office | Drug Quality Assurance |
| July 3, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Atlantis Laboratories, Inc
- FDA Inspection 1273885 - 2025-06-26
- FDA Inspection 1099349 - 2019-07-03
- FDA Inspection 953923 - 2015-10-21
- FDA Inspection 701546 - 2010-12-08
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