Tom's of Maine, Inc.
Form 483 issued May 22, 2024 · Sanford, Maine
- Inspection
- May 7 – May 22, 2024
- Investigator
- Lori M. Newman
- Observations
- 4
- Pages
- 9
- FEI number
- 1218077
In short: On May 22, 2024, FDA issued a Form 483 with 4 observations to Tom's of Maine, Inc. in Sanford, Maine (FEI 1218077) after an inspection that ran May 7 – May 22, 2024. The investigator was Lori M. Newman. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Lori M. Newman
18 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmTom's of Maine, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tom's of Maine, Inc.?
FDA listed 4 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 Tom's of Maine, Inc.?
Lori M. Newman is named on this Form 483, for the inspection of May 7 – May 22, 2024. Each investigator has a profile showing what they cite most.
When was Tom's of Maine, Inc. inspected by FDA?
The inspection ran May 7 – May 22, 2024, and the Form 483 is dated May 22, 2024.
How do I get the full Form 483 for Tom's of Maine, 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.