OASIS Medical, Inc.
FDA inspection history in Glendora, California, 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One warning letter and one Form 483, at Glendora, California.
Cited most
Across all OASIS Medical observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198(b)(2)Complaint files1
The complete OASIS Medical file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Glendora, California
One warning letter and one Form 483 · 2025 · 10 observations
Latest: Warning letter, Jul 15, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-15 | Warning letter Warning letter | Glendora, California | — | $99 |
| 2025-01-27 | 483 Form 483 | Glendora, California | 10 | $99 |
Investigators on these documents
Claudia M. Perez-Kasmarski (1)Crystal Monroy (1)Ngozi G. Offor (1)Youkeun Kim (1)
FEI number 2083373 · most recent document Jul 15, 2025
About OASIS Medical, Inc.
How many FDA Form 483s has OASIS Medical, Inc. received?
FDA Intel has 1 Form 483 on file for OASIS Medical, Inc.; the most recent is dated Jan 27, 2025.
When was OASIS Medical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for OASIS Medical, Inc. is a Form 483 dated Jan 27, 2025, for the site in Glendora, California.
What did FDA cite at OASIS Medical, Inc.?
The regulations cited most in the observations on file for OASIS Medical, Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has OASIS Medical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for OASIS Medical, Inc.; the most recent is dated Jul 15, 2025.