Brands International Corporation
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 Lakewood, New Jersey and Newmarket, Canada.
Cited most
Across all Brands International observations on file
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
The complete Brands International 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
Lakewood, New Jersey
One warning letter · 2024
Latest: Warning letter, Dec 17, 2024 →Newmarket, Canada
One Form 483 · 2024 · 19 observations
Latest: Form 483, Jun 21, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-17 | Warning letter Warning letter | Lakewood, New Jersey | — | $99 |
| 2024-06-21 | 483 Form 483 | Newmarket, Canada | 19 | $99 |
Investigators on these documents
FEI number 3007389902 · most recent document Dec 17, 2024
About Brands International Corporation
How many FDA Form 483s has Brands International Corporation received?
FDA Intel has 1 Form 483 on file for Brands International Corporation; the most recent is dated Jun 21, 2024.
When was Brands International Corporation last inspected by FDA?
The most recent FDA inspection document on file for Brands International Corporation is a Form 483 dated Jun 21, 2024, for the site in Newmarket, Canada.
What did FDA cite at Brands International Corporation?
The regulations cited most in the observations on file for Brands International Corporation are 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.25 (Personnel qualifications), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Brands International Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Brands International Corporation; the most recent is dated Dec 17, 2024.