Hightech American Industrial Lattice, Inc.
Form 483 issued January 25, 2022 · Lexington, Massachusetts
- Inspection
- Dec 15, 2021 – Jan 25, 2022
- Investigator
- Sunita Pandey
- Observations
- 1
- Pages
- 3
- FEI number
- 3003046678
In short: On January 25, 2022, FDA issued a Form 483 with 1 observation to Hightech American Industrial Lattice, Inc. in Lexington, Massachusetts (FEI 3003046678) after an inspection that ran Dec 15, 2021 – Jan 25, 2022. The investigator was Sunita Pandey. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.120 (device labeling).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.120(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (LTDI)…
This inspection in context
Sunita Pandey
5 documents · 2022–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmHightech American Industrial Lattice, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.120(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hightech American Industrial Lattice, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.120 (device labeling). The opening words of each observation are shown on this page.
Who inspected Hightech American Industrial Lattice, Inc.?
Sunita Pandey is named on this Form 483, for the inspection of Dec 15, 2021 – Jan 25, 2022. Each investigator has a profile showing what they cite most.
When was Hightech American Industrial Lattice, Inc. inspected by FDA?
The inspection ran Dec 15, 2021 – Jan 25, 2022, and the Form 483 is dated January 25, 2022.
How do I get the full Form 483 for Hightech American Industrial Lattice, Inc.?
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