Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
3 Aug 2011
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Debra M Emerson, Stacey S Degarmo
3 Aug 2011
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Debra M Emerson, Stacey S Degarmo
3 Aug 2011
21 CFR 314.80(c)(2)
Late submission of annual safety reports
Cited by Debra M Emerson, Stacey S Degarmo
3 Aug 2011
21 CFR 314.81(b)(1)(ii)
Failure to meet specifications
Cited by Debra M Emerson, Stacey S Degarmo
Inspected site
CPCovis Pharma GmBHWaltham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | 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 5 observations
The source PDF and 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