Quincy Bioscience Manufacturing Inc.
Form 483 issued March 9, 2015 · Madison, Wisconsin
- Inspection
- Feb 23 – Mar 9, 2015
- Investigators
- April L. Young· Joel D. Hustedt
- Observations
- 13
- Pages
- 7
- FEI number
- 3006486156
In short: On March 9, 2015, FDA issued a Form 483 with 13 observations to Quincy Bioscience Manufacturing Inc. in Madison, Wisconsin (FEI 3006486156) after an inspection that ran Feb 23 – Mar 9, 2015. The investigators were April L. Young and Joel D. Hustedt. 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- 01FDCA 760(b)(1)
Serious adverse events) for a non-prescription drug used in the United States has not been…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications…
This inspection in context
April L. Young
5 documents · 2014–2015
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Minnesota.
The firmQuincy Bioscience Manufacturing 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 Quincy Bioscience Manufacturing Inc.?
FDA listed 13 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Quincy Bioscience Manufacturing Inc.?
April L. Young and Joel D. Hustedt are named on this Form 483, for the inspection of Feb 23 – Mar 9, 2015. Each investigator has a profile showing what they cite most.
When was Quincy Bioscience Manufacturing Inc. inspected by FDA?
The inspection ran Feb 23 – Mar 9, 2015, and the Form 483 is dated March 9, 2015.
How do I get the full Form 483 for Quincy Bioscience Manufacturing 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.