Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
9 May 2011
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Loretta Nemchik, Meredith L Sheridan
9 May 2011
21 CFR 820.70(i)
Documentation of software validation
Cited by Loretta Nemchik, Meredith L Sheridan
9 May 2011
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Loretta Nemchik, Meredith L Sheridan
Inspected site
ABAkers Biosciences, Inc.Thorofare, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | 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 3 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