HF Acquisition Co LLC
Form 483 issued February 9, 2018 · Mukilteo, Washington
- Inspection
- Feb 6 – Feb 9, 2018
- Investigator
- Annette L. Diggs
- Observations
- 2
- Pages
- 3
- FEI number
- 3014534
In short: On February 9, 2018, FDA issued a Form 483 with 2 observations to HF Acquisition Co LLC in Mukilteo, Washington (FEI 3014534) after an inspection that ran Feb 6 – Feb 9, 2018. The investigator was Annette L. Diggs. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Packaging & labeling and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.125(a) (1×) · 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Strict control is not exercised over labeling issued for use in…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Annette L. Diggs
1 document · 2018
Cites 211.125(a) (labeling issuance) more than any other section. Most of their documents are for sites in Washington.
The firmHF Acquisition Co LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HF Acquisition Co LLC?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected HF Acquisition Co LLC?
Annette L. Diggs is named on this Form 483, for the inspection of Feb 6 – Feb 9, 2018. Each investigator has a profile showing what they cite most.
When was HF Acquisition Co LLC inspected by FDA?
The inspection ran Feb 6 – Feb 9, 2018, and the Form 483 is dated February 9, 2018.
How do I get the full Form 483 for HF Acquisition Co 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.