Overview
- 9 public-safe observations are available for this inspection.
- 3 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.
19 Sep 2022
21 CFR 111.105(e)
Quality control - verification requirements, exempted
Cited by Christopher S Fields
19 Sep 2022
21 CFR 111.105(e)
Quality control - verification requirements, exempted
Cited by Christopher S Fields
19 Sep 2022
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Christopher S Fields
19 Sep 2022
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Christopher S Fields
19 Sep 2022
21 CFR 111.315(a)
Criteria for establishing specifications; reviewed, approved
Cited by Christopher S Fields
Inspected site
BABio Answer Holdings, Inc.Hauppauge, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.315(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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