Newton Laboratories, Inc.
Form 483 issued September 17, 2021 · Conyers, Georgia
- Inspection
- Sep 13 – Sep 17, 2021
- Investigators
- Navista C. Bolton· Santos E. Camara
- Observations
- 1
- Pages
- 2
- FEI number
- 1051203
In short: On September 17, 2021, FDA issued a Form 483 with 1 observation to Newton Laboratories, Inc. in Conyers, Georgia (FEI 1051203) after an inspection that ran Sep 13 – Sep 17, 2021. The investigators were Navista C. Bolton and Santos E. Camara. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Navista C. Bolton
1 document · 2021
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Georgia.
The firmNewton Laboratories, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Newton Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Newton Laboratories, Inc.?
Navista C. Bolton and Santos E. Camara are named on this Form 483, for the inspection of Sep 13 – Sep 17, 2021. Each investigator has a profile showing what they cite most.
When was Newton Laboratories, Inc. inspected by FDA?
The inspection ran Sep 13 – Sep 17, 2021, and the Form 483 is dated September 17, 2021.
How do I get the full Form 483 for Newton 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.