Overview
- 19 public-safe observations are available for this inspection.
- 18 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Oct 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Xiaokuang Lai, Megan A Haggerty, Ramon E Martinez, Amy C Jordan
30 Oct 2009
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Xiaokuang Lai, Megan A Haggerty, Ramon E Martinez, Amy C Jordan
30 Oct 2009
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Xiaokuang Lai, Megan A Haggerty, Ramon E Martinez, Amy C Jordan
30 Oct 2009
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Xiaokuang Lai, Megan A Haggerty, Ramon E Martinez, Amy C Jordan
30 Oct 2009
21 CFR 211.63
Equipment Design, Size and Location
Cited by Xiaokuang Lai, Megan A Haggerty, Ramon E Martinez, Amy C Jordan
Inspected site
CLCitra Labs, LLCBraintree, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | 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