Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
10 Nov 2021
21 CFR 111.180(a)
Records - comp, package, labels, product received: Available
Cited by Donald J Mee, Jontae D Sanders
10 Nov 2021
21 CFR 111.260(l)(3)
Batch record - approved, released, rejected; batch
Cited by Donald J Mee, Jontae D Sanders
10 Nov 2021
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Donald J Mee, Jontae D Sanders
10 Nov 2021
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Donald J Mee, Jontae D Sanders
Inspected site
GLGolden Lab LLCJacksonville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | 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 111.95(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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