Overview
- 14 public-safe observations are available for this inspection.
- 14 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.
26 Feb 2009
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Robert J Martin, Megan A Haggerty
26 Feb 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Robert J Martin, Megan A Haggerty
26 Feb 2009
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Robert J Martin, Megan A Haggerty
26 Feb 2009
21 CFR 211.52
Washing and toilet facilities are deficient
Cited by Robert J Martin, Megan A Haggerty
26 Feb 2009
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Robert J Martin, Megan A Haggerty
Inspected site
LLLyne Laboratories, Inc.Brockton, United States
Inspection team
MAMegan A Haggerty
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 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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