Newton Laboratories, Inc.
Form 483 issued March 26, 2026 · Conyers, Georgia
- Inspection
- Mar 23 – Mar 26, 2026
- Investigators
- John D. McIntosh· Martin M. Kimani
- Observations
- 3
- Pages
- 4
- FEI number
- 1051203
In short: On March 26, 2026, FDA issued a Form 483 with 3 observations to Newton Laboratories, Inc. in Conyers, Georgia (FEI 1051203) after an inspection that ran Mar 23 – Mar 26, 2026. The investigators were John D. McIntosh and Martin M. Kimani. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability testing…
- 02
Complaint procedures are deficient in that they do not include provisions that allow for the review…
- 03
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
This inspection in context
John D. McIntosh
3 documents · 2024–2026
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Newton Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Newton Laboratories, Inc.?
John D. McIntosh and Martin M. Kimani are named on this Form 483, for the inspection of Mar 23 – Mar 26, 2026. Each investigator has a profile showing what they cite most.
When was Newton Laboratories, Inc. inspected by FDA?
The inspection ran Mar 23 – Mar 26, 2026, and the Form 483 is dated March 26, 2026.
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.