Tekweld Solutions Inc
Form 483 issued January 17, 2020 · Hauppauge, New York
- Inspection
- Jan 13 – Jan 17, 2020
- Investigator
- Rachael Moliver
- Observations
- 5
- Pages
- 4
- FEI number
- 3004965821
In short: On January 17, 2020, FDA issued a Form 483 with 5 observations to Tekweld Solutions Inc in Hauppauge, New York (FEI 3004965821) after an inspection that ran Jan 13 – Jan 17, 2020. The investigator was Rachael Moliver. Most observations concern packaging & labeling and quality system.
At a glance
3 of 5 observations on this 483 concern packaging & labeling.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There is a lack of written procedures describing in sufficient detail the receipt, identification, handling and…
- 03
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were…
- 04
Results of inspection of packaging and labeling facilities are not documented in…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmTekweld Solutions Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tekweld Solutions Inc?
FDA listed 5 observations on this Form 483, mostly about packaging & labeling and quality system. The opening words of each observation are shown on this page.
Who inspected Tekweld Solutions Inc?
Rachael Moliver is named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Tekweld Solutions Inc inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for Tekweld Solutions 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.