Surgical Technology Laboratories, Inc
Form 483 issued May 10, 2024 · Lugoff, South Carolina
- Inspection
- May 6 – May 10, 2024
- Investigator
- Gamal A. Norton
- Observations
- 2
- Pages
- 3
- FEI number
- 1825527
In short: On May 10, 2024, FDA issued a Form 483 with 2 observations to Surgical Technology Laboratories, Inc in Lugoff, South Carolina (FEI 1825527) after an inspection that ran May 6 – May 10, 2024. The investigator was Gamal A. Norton. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.120 (device labeling).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.120(b) (1×) · 820.120(d) (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 (UDI)…
- 02
Labels and labeling used for each finished product, lot, or batch, were not sufficiently…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmSurgical Technology Laboratories, 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 Surgical Technology Laboratories, Inc?
FDA listed 2 observations 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 Surgical Technology Laboratories, Inc?
Gamal A. Norton is named on this Form 483, for the inspection of May 6 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Surgical Technology Laboratories, Inc inspected by FDA?
The inspection ran May 6 – May 10, 2024, and the Form 483 is dated May 10, 2024.
How do I get the full Form 483 for Surgical Technology Laboratories, 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.