Happy Farm Botanicals Inc.
Form 483 issued March 15, 2024 · Hyattsville, Maryland
- Inspection
- Mar 12 – Mar 15, 2024
- Investigators
- John D. McIntosh· Johnny D. Nwankwo
- Observations
- 2
- Pages
- 3
- FEI number
- 3011407349
In short: On March 15, 2024, FDA issued a Form 483 with 2 observations to Happy Farm Botanicals Inc. in Hyattsville, Maryland (FEI 3011407349) after an inspection that ran Mar 12 – Mar 15, 2024. The investigators were John D. McIntosh and Johnny D. Nwankwo. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100(a) (1×) · 211.67(b)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
John D. McIntosh
3 documents · 2024–2026
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
The firmHappy Farm Botanicals Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Happy Farm Botanicals Inc.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Happy Farm Botanicals Inc.?
John D. McIntosh and Johnny D. Nwankwo are named on this Form 483, for the inspection of Mar 12 – Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was Happy Farm Botanicals Inc. inspected by FDA?
The inspection ran Mar 12 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for Happy Farm Botanicals Inc.?
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.