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.
7 Feb 2025
21 CFR 111.15(d)(2)
Pest control measures
Cited by Meredith P Soehl, Dana A Razzano, Joshua D Lopez
7 Feb 2025
21 CFR 111.455(c)
Hold - mix-up, contamination, deterioration
Cited by Meredith P Soehl, Dana A Razzano, Joshua D Lopez
7 Feb 2025
21 CFR 111.70(b)
Specifications - components
Cited by Meredith P Soehl, Dana A Razzano, Joshua D Lopez
7 Feb 2025
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Meredith P Soehl, Dana A Razzano, Joshua D Lopez
7 Feb 2025
21 CFR 111.75(c)(3)
Specifications met identity, purity, strength, comp; basis
Cited by Meredith P Soehl, Dana A Razzano, Joshua D Lopez
Inspected site
BPBactolac Pharmaceutical, Inc.Hauppauge, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | 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, 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