Litron LLC
Form 483 issued March 22, 2022 · Agawam, Massachusetts
- Inspection
- Mar 9 – Mar 22, 2022
- Investigator
- Jeffrey J. Thibodeau
- Observations
- 4
- Pages
- 7
- FEI number
- 3002574478
In short: On March 22, 2022, FDA issued a Form 483 with 4 observations to Litron LLC in Agawam, Massachusetts (FEI 3002574478) after an inspection that ran Mar 9 – Mar 22, 2022. The investigator was Jeffrey J. Thibodeau. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Procedures for changes to a specification, process and procedure have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for training and identifying training needs have…
This inspection in context
Jeffrey J. Thibodeau
7 documents · 2015–2024
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmLitron LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Litron LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Litron LLC?
Jeffrey J. Thibodeau is named on this Form 483, for the inspection of Mar 9 – Mar 22, 2022. Each investigator has a profile showing what they cite most.
When was Litron LLC inspected by FDA?
The inspection ran Mar 9 – Mar 22, 2022, and the Form 483 is dated March 22, 2022.
How do I get the full Form 483 for Litron LLC?
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.