Edmundo B. Fernandez, Inc
Form 483 issued August 18, 2016 · Bayamon, Puerto Rico
- Inspection
- Jul 27 – Aug 18, 2016
- Investigator
- Enrique Galan
- Observations
- 3
- Pages
- 2
- FEI number
- 3004655791
In short: On August 18, 2016, FDA issued a Form 483 with 3 observations to Edmundo B. Fernandez, Inc in Bayamon, Puerto Rico (FEI 3004655791) after an inspection that ran Jul 27 – Aug 18, 2016. The investigator was Enrique Galan. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Enrique Galan
1 document · 2016
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmEdmundo B. Fernandez, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edmundo B. Fernandez, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Edmundo B. Fernandez, Inc?
Enrique Galan is named on this Form 483, for the inspection of Jul 27 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was Edmundo B. Fernandez, Inc inspected by FDA?
The inspection ran Jul 27 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
How do I get the full Form 483 for Edmundo B. Fernandez, 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.