Bio Lab-St. Joseph Corp
Form 483 issued January 28, 2017 · Bayamon, Puerto Rico
- Inspection
- Nov 19, 2016 – Jan 18, 2017
- Investigators
- Laiza V. Garcia· Maricelys Mercado
- Observations
- 1
- Pages
- 12
In short: On January 28, 2017, FDA issued a Form 483 with 1 observation to Bio Lab-St. Joseph Corp in Bayamon, Puerto Rico after an inspection that ran Nov 19, 2016 – Jan 18, 2017. The investigators were Laiza V. Garcia and 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 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
This inspection in context
Laiza V. Garcia
5 documents · 2015–2019
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBio Lab-St. Joseph Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bio Lab-St. Joseph Corp?
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 Bio Lab-St. Joseph Corp?
Laiza V. Garcia and Maricelys Mercado are named on this Form 483, for the inspection of Nov 19, 2016 – Jan 18, 2017. Each investigator has a profile showing what they cite most.
When was Bio Lab-St. Joseph Corp inspected by FDA?
The inspection ran Nov 19, 2016 – Jan 18, 2017, and the Form 483 is dated January 28, 2017.
How do I get the full Form 483 for Bio Lab-St. Joseph Corp?
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.