OASIS Medical, Inc.
Form 483 issued January 27, 2025 · Glendora, California
- Inspection
- Jan 15 – Jan 27, 2025
- Investigators
- Claudia M. Perez-Kasmarski· Crystal Monroy· Ngozi G. Offor
- Observations
- 10
- Pages
- 23
- FEI number
- 2083373
In short: On January 27, 2025, FDA issued a Form 483 with 10 observations to OASIS Medical, Inc. in Glendora, California (FEI 2083373) after an inspection that ran Jan 15 – Jan 27, 2025. The investigators were Claudia M. Perez-Kasmarski, Crystal Monroy, Ngozi G. Offor and Youkeun Kim. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Complaint records are deficient in that they do not include the findings of the…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmOASIS Medical, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OASIS Medical, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected OASIS Medical, Inc.?
Claudia M. Perez-Kasmarski, Crystal Monroy, Ngozi G. Offor and Youkeun Kim are named on this Form 483, for the inspection of Jan 15 – Jan 27, 2025. Each investigator has a profile showing what they cite most.
When was OASIS Medical, Inc. inspected by FDA?
The inspection ran Jan 15 – Jan 27, 2025, and the Form 483 is dated January 27, 2025.
How do I get the full Form 483 for OASIS Medical, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.