Sheffield Pharmaceuticals LLC
Form 483 issued March 15, 2019 · New London, Connecticut
- Inspection
- Mar 11 – Mar 15, 2019
- Investigator
- Maryam Tabatabaie
- Observations
- 7
- Pages
- 5
- FEI number
- 1210513
In short: On March 15, 2019, FDA issued a Form 483 with 7 observations to Sheffield Pharmaceuticals LLC in New London, Connecticut (FEI 1210513) after an inspection that ran Mar 11 – Mar 15, 2019. The investigator was Maryam Tabatabaie. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
- 04
Procedures to ensure equipment is routinely calibrated have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmSheffield Pharmaceuticals LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sheffield Pharmaceuticals LLC?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Sheffield Pharmaceuticals LLC?
Maryam Tabatabaie is named on this Form 483, for the inspection of Mar 11 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Sheffield Pharmaceuticals LLC inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Sheffield Pharmaceuticals 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.