Trinity Sterile, Inc.
Form 483 issued March 13, 2017 · Salisbury, Maryland
- Inspection
- Feb 28 – Mar 13, 2017
- Investigator
- James Michael Simpson
- Observations
- 2
- Pages
- 6
- FEI number
- 1000123297
In short: On March 13, 2017, FDA issued a Form 483 with 2 observations to Trinity Sterile, Inc. in Salisbury, Maryland (FEI 1000123297) after an inspection that ran Feb 28 – Mar 13, 2017. The investigator was James Michael Simpson. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75(a) (1×) · 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures have not been adequately established to control product that does not…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmTrinity Sterile, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trinity Sterile, Inc.?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Trinity Sterile, Inc.?
James Michael Simpson is named on this Form 483, for the inspection of Feb 28 – Mar 13, 2017. Each investigator has a profile showing what they cite most.
When was Trinity Sterile, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 13, 2017, and the Form 483 is dated March 13, 2017.
How do I get the full Form 483 for Trinity Sterile, 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.