Grant Industries Inc.
Form 483 issued August 21, 2020 · Elmwood Park, New Jersey
- Inspection
- Aug 17 – Aug 21, 2020
- Investigators
- Anthony Donato· Tenia Bunch
- Observations
- 3
- Pages
- 3
- FEI number
- 3009862165
In short: On August 21, 2020, FDA issued a Form 483 with 3 observations to Grant Industries Inc. in Elmwood Park, New Jersey (FEI 3009862165) after an inspection that ran Aug 17 – Aug 21, 2020. The investigators were Anthony Donato and Tenia Bunch. Most observations concern quality system and facilities & equipment.
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
- 01
The firm has failed to provide sufficient documentation to ensure that personnel are trained to…
- 02
The responsibilities and procedures applicable to the Quality Unit…
- 03
The firm has failed to provide appropriate control over the input and output from…
This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmGrant Industries Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grant Industries Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Grant Industries Inc.?
Anthony Donato and Tenia Bunch are named on this Form 483, for the inspection of Aug 17 – Aug 21, 2020. Each investigator has a profile showing what they cite most.
When was Grant Industries Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 21, 2020, and the Form 483 is dated August 21, 2020.
How do I get the full Form 483 for Grant Industries 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.