Professional Contract Sterilization
Form 483 issued February 16, 2024 · Taunton, Massachusetts
- Inspection
- Nov 6, 2023 – Feb 16, 2024
- Investigators
- Diane M. Biron· Eric C. Schmitt
- Observations
- 6
- Pages
- 11
- FEI number
- 1000121050
In short: On February 16, 2024, FDA issued a Form 483 with 6 observations to Professional Contract Sterilization in Taunton, Massachusetts (FEI 1000121050) after an inspection that ran Nov 6, 2023 – Feb 16, 2024. The investigators were Diane M. Biron and Eric C. Schmitt. Most observations concern production & process controls and management controls.
At a glance
4 of 6 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
In-process inspections, tests, or other verificaition activities and…
- 04
Procedmes for training and identifying training needs…
This inspection in context
Diane M. Biron
1 document · 2024
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmProfessional Contract Sterilization history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Contract Sterilization?
FDA listed 6 observations on this Form 483, mostly about production & process controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Professional Contract Sterilization?
Diane M. Biron and Eric C. Schmitt are named on this Form 483, for the inspection of Nov 6, 2023 – Feb 16, 2024. Each investigator has a profile showing what they cite most.
When was Professional Contract Sterilization inspected by FDA?
The inspection ran Nov 6, 2023 – Feb 16, 2024, and the Form 483 is dated February 16, 2024.
How do I get the full Form 483 for Professional Contract Sterilization?
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.