Tom's of Maine, Inc.
FDA inspection history across 3 sites, 2002 to 2024
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2002: one warning letter; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Kennebunk, Maine.
- 2024One warning letter and one Form 483, at New York, New York and Sanford, Maine.
Cited most
Across all Tom's of Maine observations on file
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.58Maintenance1
The complete Tom's of Maine file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
New York, New York
One warning letter · 2024
Latest: Warning letter, Nov 5, 2024 →Sanford, Maine
One Form 483 · 2024 · 4 observations
Latest: Form 483, May 22, 2024 →Kennebunk, Maine
One warning letter · 2002
Latest: Warning letter, Nov 29, 2002 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-05 | Warning letter Warning letter | New York, New York | — | $99 |
| 2024-05-22 | 483 Form 483 | Sanford, Maine | 4 | $99 |
| 2002-11-29 | Warning letter Warning letter | Kennebunk, Maine | — | $99 |
Investigators on these documents
FEI number 1218077 · most recent document Nov 5, 2024
About Tom's of Maine, Inc.
How many FDA Form 483s has Tom's of Maine, Inc. received?
FDA Intel has 1 Form 483 on file for Tom's of Maine, Inc.; the most recent is dated May 22, 2024.
When was Tom's of Maine, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tom's of Maine, Inc. is a Form 483 dated May 22, 2024, for the site in Sanford, Maine.
What did FDA cite at Tom's of Maine, Inc.?
The regulations cited most in the observations on file for Tom's of Maine, Inc. are 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Tom's of Maine, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Tom's of Maine, Inc.; the most recent is dated Nov 5, 2024.