King Bio Inc
Form 483 issued August 12, 2021 · Asheville, North Carolina
- Inspection
- Aug 2 – Aug 12, 2021
- Investigators
- Bonita S. Chester· Jared P. Stevens
- Observations
- 7
- Pages
- 5
- FEI number
- 1053442
In short: On August 12, 2021, FDA issued a Form 483 with 7 observations to King Bio Inc in Asheville, North Carolina (FEI 1053442) after an inspection that ran Aug 2 – Aug 12, 2021. The investigators were Bonita S. Chester and Jared P. Stevens. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into do not include…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Employees are not given training in the particular operations they perform as…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmKing Bio Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 King Bio Inc?
FDA listed 7 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected King Bio Inc?
Bonita S. Chester and Jared P. Stevens are named on this Form 483, for the inspection of Aug 2 – Aug 12, 2021. Each investigator has a profile showing what they cite most.
When was King Bio Inc inspected by FDA?
The inspection ran Aug 2 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.
How do I get the full Form 483 for King Bio 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.