Newton Laboratories, Inc.
Form 483 issued March 30, 2018 · Conyers, Georgia
- Inspection
- Mar 26 – Mar 30, 2018
- Investigators
- Rachael L. Cook· Susan O. Oladeji
- Observations
- 8
- Pages
- 6
- FEI number
- 1051203
In short: On March 30, 2018, FDA issued a Form 483 with 8 observations to Newton Laboratories, Inc. in Conyers, Georgia (FEI 1051203) after an inspection that ran Mar 26 – Mar 30, 2018. The investigators were Rachael L. Cook and Susan O. Oladeji. Most observations concern quality system and production.
At a glance
5 of 8 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Complaint records are deficient in that they do not document the reason and the individual making…
This inspection in context
Rachael L. Cook
8 documents · 2016–2020
Cites 211.42 (design and construction features) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Newton Laboratories, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Newton Laboratories, Inc.?
Rachael L. Cook and Susan O. Oladeji are named on this Form 483, for the inspection of Mar 26 – Mar 30, 2018. Each investigator has a profile showing what they cite most.
When was Newton Laboratories, Inc. inspected by FDA?
The inspection ran Mar 26 – Mar 30, 2018, and the Form 483 is dated March 30, 2018.
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.