Bestco, LLC
Form 483 issued May 17, 2019 · Mooresville, North Carolina
- Inspection
- May 13 – May 17, 2019
- Investigator
- Sonya M. Edmonds
- Observations
- 3
- Pages
- 3
- FEI number
- 2210783
In short: On May 17, 2019, FDA issued a Form 483 with 3 observations to Bestco, LLC in Mooresville, North Carolina (FEI 2210783) after an inspection that ran May 13 – May 17, 2019. The investigator was Sonya M. Edmonds. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are lacking which describe in sufficient detail…
- 02
Records are not maintained so that data therein can be reviewed (OA) to evaluate the quality…
- 03
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmBestco, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bestco, LLC?
FDA listed 3 observations on this Form 483, mostly about materials, quality system and production. The opening words of each observation are shown on this page.
Who inspected Bestco, LLC?
Sonya M. Edmonds is named on this Form 483, for the inspection of May 13 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was Bestco, LLC inspected by FDA?
The inspection ran May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for Bestco, LLC?
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.