Linatech, Lie
Form 483 issued November 8, 2019 · Sunnyvale, California
- Inspection
- Nov 4 – Nov 8, 2019
- Investigators
- Amogh Pathi· Eric J. Heinze
- Observations
- 9
- Pages
- 6
- FEI number
- 3007037519
In short: On November 8, 2019, FDA issued a Form 483 with 9 observations to Linatech, Lie in Sunnyvale, California (FEI 3007037519) after an inspection that ran Nov 4 – Nov 8, 2019. The investigators were Amogh Pathi and Eric J. Heinze. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and capa account for 7 of 9 observations.
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
Records for complaints where no investigation was made do…
- 03
No management representative had been appointed to ensure that quality system requirements are met, and to…
- 04
The results and/or dates of management…
This inspection in context
Amogh Pathi
1 document · 2019
Cites 820.20(a) (management responsibility) more than any other section. Most of their documents are for sites in California.
The firmLinatech, Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Linatech, Lie?
FDA listed 9 observations on this Form 483, mostly about management controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Linatech, Lie?
Amogh Pathi and Eric J. Heinze are named on this Form 483, for the inspection of Nov 4 – Nov 8, 2019. Each investigator has a profile showing what they cite most.
When was Linatech, Lie inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2019, and the Form 483 is dated November 8, 2019.
How do I get the full Form 483 for Linatech, Lie?
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.