Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Feb 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
5 Feb 2026
21 CFR 211.180(e)(1)
Representative Number of Batches for Annual Review
Cited by Scott T Ballard, Ramon L Gonzalez-Prieto
Inspected site
FIFenwal International, Inc.Maricao, United States
Inspection team
RLRamon L Gonzalez-Prieto
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 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | 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 9 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