Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
8 Nov 2017
21 CFR 820.30(h)
Incorrect translation to production specifications
Cited by Christina L Bigham
8 Nov 2017
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Christina L Bigham
8 Nov 2017
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Christina L Bigham
Inspected site
LCLiebel-Flarsheim Company LLCCincinnati, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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