Dr. Brite LLC
FDA inspection history across 2 sites, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Santa Ana, California and Fullerton, California.
Cited most
Across all Dr. Brite observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Dr. Brite 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
Santa Ana, California
One warning letter · 2024
Latest: Warning letter, Nov 21, 2024 →Fullerton, California
One Form 483 · 2024 · 6 observations
Latest: Form 483, Apr 5, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-21 | Warning letter Warning letter | Santa Ana, California | — | $99 |
| 2024-04-05 | 483 Form 483 | Fullerton, California | 6 | $99 |
Investigators on these documents
FEI number 3016665985 · most recent document Nov 21, 2024
About Dr. Brite LLC
How many FDA Form 483s has Dr. Brite LLC received?
FDA Intel has 1 Form 483 on file for Dr. Brite LLC; the most recent is dated Apr 5, 2024.
When was Dr. Brite LLC last inspected by FDA?
The most recent FDA inspection document on file for Dr. Brite LLC is a Form 483 dated Apr 5, 2024, for the site in Fullerton, California.
What did FDA cite at Dr. Brite LLC?
The regulations cited most in the observations on file for Dr. Brite LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Dr. Brite LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Dr. Brite LLC; the most recent is dated Nov 21, 2024.