Pinnacle Biologies Inc
Form 483 issued March 15, 2016 · Chicago, Illinois
- Inspection
- Feb 18 – Mar 15, 2016
- Investigators
- David Gasparovich· That Q. Dang
- Observations
- 2
- Pages
- 3
- FEI number
- 3010119152
In short: On March 15, 2016, FDA issued a Form 483 with 2 observations to Pinnacle Biologies Inc in Chicago, Illinois (FEI 3010119152) after an inspection that ran Feb 18 – Mar 15, 2016. The investigators were David Gasparovich and That Q. Dang. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Corrective and preventive action activities and/or results have not…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmPinnacle Biologies Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pinnacle Biologies Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Pinnacle Biologies Inc?
David Gasparovich and That Q. Dang are named on this Form 483, for the inspection of Feb 18 – Mar 15, 2016. Each investigator has a profile showing what they cite most.
When was Pinnacle Biologies Inc inspected by FDA?
The inspection ran Feb 18 – Mar 15, 2016, and the Form 483 is dated March 15, 2016.
How do I get the full Form 483 for Pinnacle Biologies 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.