Superior Surgical, Lie
Form 483 issued March 10, 2022 · Pottstown, Pennsylvania
- Inspection
- Mar 3 – Mar 10, 2022
- Investigator
- Edward D. McDonald
- Observations
- 4
- Pages
- 4
- FEI number
- 3008017452
In short: On March 10, 2022, FDA issued a Form 483 with 4 observations to Superior Surgical, Lie in Pottstown, Pennsylvania (FEI 3008017452) after an inspection that ran Mar 3 – Mar 10, 2022. The investigator was Edward D. McDonald. Most observations concern management controls and cAPA.
At a glance
Management controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility has not reviewed the suitability and effectiveness…
- 02
Quality audits have not…
- 03
Corrective and preventive action activities and/or results…
- 04
Records of acceptable suppliers have…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSuperior Surgical, Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Superior Surgical, Lie?
FDA listed 4 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Superior Surgical, Lie?
Edward D. McDonald is named on this Form 483, for the inspection of Mar 3 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Superior Surgical, Lie inspected by FDA?
The inspection ran Mar 3 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
How do I get the full Form 483 for Superior Surgical, Lie?
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.