Form 483, Jan 16, 2023
Form 483 issued January 16, 2023 · Lee, Massachusetts
- Inspection
- Jan 16, 2023
- Observations
- 6
- Pages
- 3
In short: On January 16, 2023, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Lee, Massachusetts after an inspection that ran Jan 16, 2023.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Cleaning procedures are not…
- 04
Adequate contamination control during the manufacture of drug product is…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 16, 2023, and the Form 483 is dated January 16, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.