NeoBiotech Global Corporation
Form 483 issued May 13, 2019 · Auburn, Washington
- Inspection
- Apr 26 – May 13, 2019
- Investigators
- Andrew K. Haack· Peter S. Kessler
- Observations
- 8
- Pages
- 5
- FEI number
- 3011869023
In short: On May 13, 2019, FDA issued a Form 483 with 8 observations to NeoBiotech Global Corporation in Auburn, Washington (FEI 3011869023) after an inspection that ran Apr 26 – May 13, 2019. The investigators were Andrew K. Haack and Peter S. Kessler. 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
There is no quality…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug product are not…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmNeoBiotech Global Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NeoBiotech Global Corporation?
FDA listed 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected NeoBiotech Global Corporation?
Andrew K. Haack and Peter S. Kessler are named on this Form 483, for the inspection of Apr 26 – May 13, 2019. Each investigator has a profile showing what they cite most.
When was NeoBiotech Global Corporation inspected by FDA?
The inspection ran Apr 26 – May 13, 2019, and the Form 483 is dated May 13, 2019.
How do I get the full Form 483 for NeoBiotech Global Corporation?
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.