Sanitor Corporation
FDA inspection history in Stanton, California, 2021 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s and one warning letter, at Stanton, California.
- 2021The longest 483 on file: 13 observations over 9 pages at Stanton, California.
Cited most
Across all Sanitor observations on file
- 21 CFR 211.166(a)Stability testing3
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.25(a)Personnel qualifications2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
The complete Sanitor file.
All 3 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
Stanton, California
Two Form 483s and one warning letter · 2021 to 2023 · 18 observations
Latest: Form 483, Apr 14, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-14 | 483 Form 483 | Stanton, California | 5 | $99 |
| 2021-11-29 | Warning letter Warning letter | Stanton, California | — | $99 |
| 2021-06-03 | 483 Form 483 | Stanton, California | 13 | $99 |
Investigators on these documents
Christopher R. Czajka (1)Hung H. Do (1)Khoa Nathan V. Tran (1)
FEI number 3005871025 · most recent document Apr 14, 2023
About Sanitor Corporation
How many FDA Form 483s has Sanitor Corporation received?
FDA Intel has 2 Form 483s on file for Sanitor Corporation; the most recent is dated Apr 14, 2023.
When was Sanitor Corporation last inspected by FDA?
The most recent FDA inspection document on file for Sanitor Corporation is a Form 483 dated Apr 14, 2023, for the site in Stanton, California.
What did FDA cite at Sanitor Corporation?
The regulations cited most in the observations on file for Sanitor Corporation are 21 CFR 211.166(a) (Stability testing), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times.
Has Sanitor Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sanitor Corporation; the most recent is dated Nov 29, 2021.