Holl Hemp LLC
Form 483 issued November 19, 2024 · Vancouver, Washington
- Inspection
- Nov 13 – Nov 19, 2024
- Investigator
- Bryan L. McGuckin
- Observations
- 9
- Pages
- 5
- FEI number
- 3024522473
In short: On November 19, 2024, FDA issued a Form 483 with 9 observations to Holl Hemp LLC in Vancouver, Washington (FEI 3024522473) after an inspection that ran Nov 13 – Nov 19, 2024. The investigator was Bryan L. McGuckin. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Each lot of components is not withheld from use until the lot has been sampled, tested…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmHoll Hemp LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Holl Hemp LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Holl Hemp LLC?
Bryan L. McGuckin is named on this Form 483, for the inspection of Nov 13 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was Holl Hemp LLC inspected by FDA?
The inspection ran Nov 13 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Holl Hemp LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.