Goodwin Biotechnology, Inc
Form 483 issued April 10, 2019 · Plantation, Florida
- Inspection
- Apr 1 – Apr 10, 2019
- Investigators
- Jose Velez· Susan T. Hadman
- Observations
- 3
- Pages
- 5
- FEI number
- 3001861303
In short: On April 10, 2019, FDA issued a Form 483 with 3 observations to Goodwin Biotechnology, Inc in Plantation, Florida (FEI 3001861303) after an inspection that ran Apr 1 – Apr 10, 2019. The investigators were Jose Velez and Susan T. Hadman. Most observations concern quality system and biologics CGMP.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 610.12
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmGoodwin Biotechnology, Inc history
The site's inspection history, in date order.
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 Goodwin Biotechnology, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and biologics CGMP. The opening words of each observation are shown on this page.
Who inspected Goodwin Biotechnology, Inc?
Jose Velez and Susan T. Hadman are named on this Form 483, for the inspection of Apr 1 – Apr 10, 2019. Each investigator has a profile showing what they cite most.
When was Goodwin Biotechnology, Inc inspected by FDA?
The inspection ran Apr 1 – Apr 10, 2019, and the Form 483 is dated April 10, 2019.
How do I get the full Form 483 for Goodwin Biotechnology, 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.