Intercos America, Inc.
Form 483 issued October 9, 2024 · Congers, New York
- Investigators
- Emmanuel T. Donyina· Syeda N. Mahazabin
- Observations
- 1
- Pages
- 2
- FEI number
- 3003361127
In short: On October 9, 2024, FDA issued a Form 483 with 1 observation to Intercos America, Inc. in Congers, New York (FEI 3003361127). The investigators were Emmanuel T. Donyina and Syeda N. Mahazabin. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Emmanuel T. Donyina
3 documents · 2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmIntercos America, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intercos America, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Intercos America, Inc.?
Emmanuel T. Donyina and Syeda N. Mahazabin are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Intercos America, Inc. inspected by FDA?
This Form 483 is dated October 9, 2024.
How do I get the full Form 483 for Intercos America, 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.