Grafor, Inc
Form 483 issued May 6, 2016 · Juana Diaz, Puerto Rico
- Inspection
- Apr 25 – May 6, 2016
- Investigator
- Jose Velez
- Observations
- 9
- Pages
- 6
- FEI number
- 1000222295
In short: On May 6, 2016, FDA issued a Form 483 with 9 observations to Grafor, Inc in Juana Diaz, Puerto Rico (FEI 1000222295) after an inspection that ran Apr 25 – May 6, 2016. The investigator was Jose Velez. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmGrafor, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grafor, Inc?
FDA listed 9 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Grafor, Inc?
Jose Velez is named on this Form 483, for the inspection of Apr 25 – May 6, 2016. Each investigator has a profile showing what they cite most.
When was Grafor, Inc inspected by FDA?
The inspection ran Apr 25 – May 6, 2016, and the Form 483 is dated May 6, 2016.
How do I get the full Form 483 for Grafor, 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.