Overview
- 19 public-safe observations are available for this inspection.
- 18 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Feb 2011
21 CFR 111.20(d)(1)(iv)
Physical plant - temperature, humidity controls
Cited by Meredith P Soehl
Inspected site
FLFB Laboratories Inc.Hauppauge, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.315(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 observations
Every observation in full, 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