Biosynergy, Inc
Form 483 issued January 25, 2018 · Elk Grove Village, Illinois
- Inspection
- Dec 19, 2017 – Jan 25, 2018
- Investigator
- Amanda Dinaro
- Observations
- 7
- Pages
- 6
- FEI number
- 1419300
In short: On January 25, 2018, FDA issued a Form 483 with 7 observations to Biosynergy, Inc in Elk Grove Village, Illinois (FEI 1419300) after an inspection that ran Dec 19, 2017 – Jan 25, 2018. The investigator was Amanda Dinaro. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and management controls account for 6 of 7 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
Procedures for corrective and preventive action have…
- 04
Procedures have not been established to control product that does not…
This inspection in context
Amanda Dinaro
7 documents · 2017–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Illinois.
The firmBiosynergy, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biosynergy, Inc?
FDA listed 7 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Biosynergy, Inc?
Amanda Dinaro is named on this Form 483, for the inspection of Dec 19, 2017 – Jan 25, 2018. Each investigator has a profile showing what they cite most.
When was Biosynergy, Inc inspected by FDA?
The inspection ran Dec 19, 2017 – Jan 25, 2018, and the Form 483 is dated January 25, 2018.
How do I get the full Form 483 for Biosynergy, 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.