King Bio Inc
Form 483 issued July 28, 2023 · Asheville, North Carolina
- Inspection
- Jul 20 – Jul 28, 2023
- Investigators
- Dorothy P. Kramer· Libia M. Lugo
- Observations
- 2
- Pages
- 4
- FEI number
- 1053442
In short: On July 28, 2023, FDA issued a Form 483 with 2 observations to King Bio Inc in Asheville, North Carolina (FEI 1053442) after an inspection that ran Jul 20 – Jul 28, 2023. The investigators were Dorothy P. Kramer and Libia M. Lugo. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at King Bio Inc?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected King Bio Inc?
Dorothy P. Kramer and Libia M. Lugo are named on this Form 483, for the inspection of Jul 20 – Jul 28, 2023. Each investigator has a profile showing what they cite most.
When was King Bio Inc inspected by FDA?
The inspection ran Jul 20 – Jul 28, 2023, and the Form 483 is dated July 28, 2023.
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.