Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
1 Apr 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Megan A Haggerty, Ramon E Martinez
1 Apr 2010
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Megan A Haggerty, Ramon E Martinez
1 Apr 2010
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Megan A Haggerty, Ramon E Martinez
1 Apr 2010
21 CFR 211.84(d)(6)
Microbiological Contamination Exam
Cited by Megan A Haggerty, Ramon E Martinez
1 Apr 2010
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Megan A Haggerty, Ramon E Martinez
Inspected site
CMCuria Massachusetts, Inc.Burlington, 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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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