STERITECH, INC
Form 483 issued February 10, 2021 · Salinas, Puerto Rico
- Inspection
- Feb 3 – Feb 10, 2021
- Investigator
- Maricelys Mercado
- Observations
- 1
- Pages
- 5
- FEI number
- 2648209
In short: On February 10, 2021, FDA issued a Form 483 with 1 observation to STERITECH, INC in Salinas, Puerto Rico (FEI 2648209) after an inspection that ran Feb 3 – Feb 10, 2021. The investigator was Maricelys Mercado. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
This inspection in context
Maricelys Mercado
2 documents · 2017–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSTERITECH, INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STERITECH, INC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected STERITECH, INC?
Maricelys Mercado is named on this Form 483, for the inspection of Feb 3 – Feb 10, 2021. Each investigator has a profile showing what they cite most.
When was STERITECH, INC inspected by FDA?
The inspection ran Feb 3 – Feb 10, 2021, and the Form 483 is dated February 10, 2021.
How do I get the full Form 483 for STERITECH, 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.