GADAL Laboratories, Inc.
Form 483 issued April 28, 2016 · Miami, Florida
- Inspection
- Jan 26 – Apr 28, 2016
- Investigator
- Jennifer Lalama
- Observations
- 5
- Pages
- 4
- FEI number
- 3008611487
In short: On April 28, 2016, FDA issued a Form 483 with 5 observations to GADAL Laboratories, Inc. in Miami, Florida (FEI 3008611487) after an inspection that ran Jan 26 – Apr 28, 2016. The investigator was Jennifer Lalama. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The suitability of all testing methods is not verified under…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Written procedures are not followed for evaluations conducted at least (b) (4) to review records associated…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmGADAL Laboratories, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GADAL Laboratories, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected GADAL Laboratories, Inc.?
Jennifer Lalama is named on this Form 483, for the inspection of Jan 26 – Apr 28, 2016. Each investigator has a profile showing what they cite most.
When was GADAL Laboratories, Inc. inspected by FDA?
The inspection ran Jan 26 – Apr 28, 2016, and the Form 483 is dated April 28, 2016.
How do I get the full Form 483 for GADAL Laboratories, 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.