Somerville Acquisitions Co., Inc.
Form 483 issued June 4, 2025 · Flemington, New Jersey
- Inspection
- May 12 – Jun 4, 2025
- Observations
- 6
- Pages
- 25
- FEI number
- 3004099380
In short: On June 4, 2025, FDA issued a Form 483 with 6 observations to Somerville Acquisitions Co., Inc. in Flemington, New Jersey (FEI 3004099380) after an inspection that ran May 12 – Jun 4, 2025. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not include reliable…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Somerville Acquisitions Co., Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
When was Somerville Acquisitions Co., Inc. inspected by FDA?
The inspection ran May 12 – Jun 4, 2025, and the Form 483 is dated June 4, 2025.
How do I get the full Form 483 for Somerville Acquisitions Co., 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.