King Bio Inc
FDA inspection history in Asheville, North Carolina, 2018 to 2023
- 2
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2018: one close-out letter; 2019: one close-out letter; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–23Two close-out letters and two Form 483s, at Asheville, North Carolina.
- 2021The longest 483 on file: 7 observations over 5 pages at Asheville, North Carolina.
Cited most
Across all King Bio observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.184(c)Component, drug product container, closure, and labeling records1
- 21 CFR 211.192Production record review1
The complete King Bio file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Asheville, North Carolina
Two Form 483s and two close-out letters · 2018 to 2023 · 9 observations
Latest: Form 483, Jul 28, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-28 | 483 Form 483 | Asheville, North Carolina | 2 | $99 |
| 2021-08-12 | 483 Form 483 | Asheville, North Carolina | 7 | $99 |
| 2019-03-20 | Close-out Close-out letter | Asheville, North Carolina | — | $99 |
| 2018-01-11 | Close-out Close-out letter | Asheville, North Carolina | — | $99 |
Investigators on these documents
Bonita S. Chester (1)Dorothy P. Kramer (1)Jared P. Stevens (1)Libia M. Lugo (1)
FEI number 1053442 · most recent document Jul 28, 2023
About King Bio Inc
How many FDA Form 483s has King Bio Inc received?
FDA Intel has 2 Form 483s on file for King Bio Inc; the most recent is dated Jul 28, 2023.
When was King Bio Inc last inspected by FDA?
The most recent FDA inspection document on file for King Bio Inc is a Form 483 dated Jul 28, 2023, for the site in Asheville, North Carolina.
What did FDA cite at King Bio Inc?
The regulations cited most in the observations on file for King Bio Inc are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.