Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Oct 2018
21 CFR 111.10(b)(6)
Hair restraints
Cited by Jared P Stevens, James Betz, Myckie M Jacobsen, Alphonso A Haupt, Hristu B Chepa
26 Oct 2018
21 CFR 111.10(b)(8)
Food, gum, beverages, tobacco
Cited by Jared P Stevens, James Betz, Myckie M Jacobsen, Alphonso A Haupt, Hristu B Chepa
26 Oct 2018
21 CFR 111.14(a)
Personnel - records - retention
Cited by Jared P Stevens, James Betz, Myckie M Jacobsen, Alphonso A Haupt, Hristu B Chepa
26 Oct 2018
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Jared P Stevens, James Betz, Myckie M Jacobsen, Alphonso A Haupt, Hristu B Chepa
26 Oct 2018
21 CFR 111.20(f)
Physical plant - bulbs, fixtures, skylights
Cited by Jared P Stevens, James Betz, Myckie M Jacobsen, Alphonso A Haupt, Hristu B Chepa
Inspected site
MDMBBR Distribution LLCMyrtle Beach, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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