Gasco Industrial Corp
Form 483 issued February 27, 2026 · Gurabo, Puerto Rico
- Inspection
- Feb 17 – Feb 27, 2026
- Investigators
- Ivis L. Negron Torres· Jose Velez
- Observations
- 13
- Pages
- 20
- FEI number
- 3010222586
In short: On February 27, 2026, FDA issued a Form 483 with 13 observations to Gasco Industrial Corp in Gurabo, Puerto Rico (FEI 3010222586) after an inspection that ran Feb 17 – Feb 27, 2026. The investigators were Ivis L. Negron Torres and Jose Velez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Drug products failing to meet established standards, specifications and quality control…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Ivis L. Negron Torres
6 documents · 2017–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmGasco Industrial Corp history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gasco Industrial Corp?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Gasco Industrial Corp?
Ivis L. Negron Torres and Jose Velez are named on this Form 483, for the inspection of Feb 17 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was Gasco Industrial Corp inspected by FDA?
The inspection ran Feb 17 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for Gasco Industrial 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.