GADAL Laboratories, Inc.
Form 483 issued February 17, 2023 · Miami, Florida
- Inspection
- Feb 13 – Feb 17, 2023
- Investigator
- Steven A. Brettler
- Observations
- 12
- Pages
- 11
- FEI number
- 3008611487
In short: On February 17, 2023, FDA issued a Form 483 with 12 observations to GADAL Laboratories, Inc. in Miami, Florida (FEI 3008611487) after an inspection that ran Feb 13 – Feb 17, 2023. The investigator was Steven A. Brettler. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not reviewed and approved by…
- 02
The establishment of test procedures including any changes thereto, are not reviewed and approved by…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GADAL Laboratories, Inc.?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected GADAL Laboratories, Inc.?
Steven A. Brettler is named on this Form 483, for the inspection of Feb 13 – Feb 17, 2023. Each investigator has a profile showing what they cite most.
When was GADAL Laboratories, Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2023, and the Form 483 is dated February 17, 2023.
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.