Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Dec 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
8 Dec 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
8 Dec 2023
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
8 Dec 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
8 Dec 2023
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
Inspected site
GIGasco Industrial Corp.Gurabo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere