FDA Inspection
OLAX Corp.OLAX Corp. – FDA Inspection, Feb 4, 2013
Record Details
This FDA Inspection record concerns OLAX Corp., with an inspection on February 4, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OLAX Corp.
- Inspection Date
- February 4, 2013
- Product Type
- Drugs
View Company Profile
ID · 41aaaaf7-16ea-4546-85d7-7076c54e2a8e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 817363
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
9- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.105Quality control - ensure quality; package, labeled, master record
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OLAX Corp.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2025 | Not classified | Florida District Office | |
| August 1, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 10, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for OLAX Corp.
- FDA Inspection 1229287 - 2025-12-09
- FDA Inspection 1020028 - 2017-08-01
- FDA Inspection 858675 - 2013-12-10
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