Brands International Corporation
Form 483 issued June 21, 2024 · Newmarket, Canada
- Inspection
- Jun 17 – Jun 21, 2024
- Investigators
- Crystal Monroy· Jose E. Melendez
- Observations
- 19
- Pages
- 16
- FEI number
- 3007389902
In short: On June 21, 2024, FDA issued a Form 483 with 19 observations to Brands International Corporation in Newmarket, Canada (FEI 3007389902) after an inspection that ran Jun 17 – Jun 21, 2024. The investigators were Crystal Monroy and Jose E. Melendez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and laboratory controls account for 12 of 19 observations.
Most cited: 21 CFR 211.165 (3×) · 211.25 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve or reject, all components, drug…
- 02
Investigations of an unexplained discrepancy, or a failure of a batch or any of its components…
- 03
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBrands International Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brands International Corporation?
FDA listed 19 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Brands International Corporation?
Crystal Monroy and Jose E. Melendez are named on this Form 483, for the inspection of Jun 17 – Jun 21, 2024. Each investigator has a profile showing what they cite most.
When was Brands International Corporation inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2024, and the Form 483 is dated June 21, 2024.
How do I get the full Form 483 for Brands International Corporation?
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.