Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Glove condition
Cited by Edna J Hidalgo, Michelle L Tripp, Krystina M Jackson
Precautions against contamination--micro, foreign substances
Cited by Edna J Hidalgo, Michelle L Tripp, Krystina M Jackson
Sufficient space
Cited by Edna J Hidalgo, Michelle L Tripp, Krystina M Jackson
Floors, walls and ceilings
Cited by Edna J Hidalgo, Michelle L Tripp, Krystina M Jackson
Screening
Cited by Edna J Hidalgo, Michelle L Tripp, Krystina M Jackson
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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