The Harvard Drug Group LLC dba Major
Form 483 issued March 20, 2026 · La Vergne, Tennessee
- Inspection
- Mar 16 – Mar 20, 2026
- Investigators
- Demario L. Walls· Nelson N. Ayangho· Sarah E. Venti
- Observations
- 1
- Pages
- 4
- FEI number
- 1818658
In short: On March 20, 2026, FDA issued a Form 483 with 1 observation to The Harvard Drug Group LLC dba Major in La Vergne, Tennessee (FEI 1818658) after an inspection that ran Mar 16 – Mar 20, 2026. The investigators were Demario L. Walls, Nelson N. Ayangho and Sarah E. Venti. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmThe Harvard Drug Group LLC dba Major history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Harvard Drug Group LLC dba Major?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 The Harvard Drug Group LLC dba Major?
Demario L. Walls, Nelson N. Ayangho and Sarah E. Venti are named on this Form 483, for the inspection of Mar 16 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was The Harvard Drug Group LLC dba Major inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for The Harvard Drug Group LLC dba Major?
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