Premier Brands of America Inc
Form 483 issued May 16, 2022 · Orangeburg, New York
- Inspection
- May 9 – May 16, 2022
- Investigator
- Rachael O. Oyewole
- Observations
- 6
- Pages
- 6
- FEI number
- 2434554
In short: On May 16, 2022, FDA issued a Form 483 with 6 observations to Premier Brands of America Inc in Orangeburg, New York (FEI 2434554) after an inspection that ran May 9 – May 16, 2022. The investigator was Rachael O. Oyewole. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Rachael O. Oyewole
10 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPremier Brands of America Inc history
The site's inspection history, in date order.
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 Premier Brands of America Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected Premier Brands of America Inc?
Rachael O. Oyewole is named on this Form 483, for the inspection of May 9 – May 16, 2022. Each investigator has a profile showing what they cite most.
When was Premier Brands of America Inc inspected by FDA?
The inspection ran May 9 – May 16, 2022, and the Form 483 is dated May 16, 2022.
How do I get the full Form 483 for Premier Brands of America 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.