Newton Laboratories, Inc.
FDA inspection history in Conyers, Georgia, 2001 to 2026
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2001: one warning letter; 2018: one Form 483; 2019: one close-out letter; 2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at Conyers, Georgia.
- 2018–21Two Form 483s and one close-out letter, at Conyers, Georgia.
- 2018The longest 483 on file: 8 observations over 6 pages at Conyers, Georgia.
- 2026One Form 483, at Conyers, Georgia.
Cited most
Across all Newton Laboratories observations on file
- 21 CFR 211.198Complaint files2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.180(e)(2)General requirements1
The complete Newton Laboratories file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Conyers, Georgia
Three Form 483s, one close-out letter and one warning letter · 2001 to 2026 · 12 observations
Latest: Form 483, Mar 26, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-26 | 483 Form 483 | Conyers, Georgia | 3 | $99 |
| 2021-09-17 | 483 Form 483 | Conyers, Georgia | 1 | $99 |
| 2019-04-23 | Close-out Close-out letter | Conyers, Georgia | — | $99 |
| 2018-03-30 | 483 Form 483 | Conyers, Georgia | 8 | $99 |
| 2001-12-06 | Warning letter Warning letter | Conyers, Georgia | — | $99 |
Investigators on these documents
John D. McIntosh (1)Martin M. Kimani (1)Navista C. Bolton (1)Rachael L. Cook (1)Santos E. Camara (1)Susan O. Oladeji (1)
FEI number 1051203 · most recent document Mar 26, 2026
About Newton Laboratories, Inc.
How many FDA Form 483s has Newton Laboratories, Inc. received?
FDA Intel has 3 Form 483s on file for Newton Laboratories, Inc.; the most recent is dated Mar 26, 2026.
When was Newton Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Newton Laboratories, Inc. is a Form 483 dated Mar 26, 2026, for the site in Conyers, Georgia.
What did FDA cite at Newton Laboratories, Inc.?
The regulations cited most in the observations on file for Newton Laboratories, Inc. are 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Newton Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Newton Laboratories, Inc.; the most recent is dated Dec 6, 2001.