Millers of Wyckoff, Inc.
Form 483 issued October 9, 2020 · Wyckoff, New Jersey
- Inspection
- Sep 16 – Oct 9, 2020
- Investigator
- Tonia F. Bernard
- Observations
- 2
- Pages
- 4
- FEI number
- 3004600183
In short: On October 9, 2020, FDA issued a Form 483 with 2 observations to Millers of Wyckoff, Inc. in Wyckoff, New Jersey (FEI 3004600183) after an inspection that ran Sep 16 – Oct 9, 2020. The investigator was Tonia F. Bernard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.46 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Hazardous drugs were produced without providing adequate cleaning of utensils…
- 02
Inadequate pressure differentials between higher quality air rooms and lower quality…
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmMillers of Wyckoff, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Millers of Wyckoff, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Millers of Wyckoff, Inc.?
Tonia F. Bernard is named on this Form 483, for the inspection of Sep 16 – Oct 9, 2020. Each investigator has a profile showing what they cite most.
When was Millers of Wyckoff, Inc. inspected by FDA?
The inspection ran Sep 16 – Oct 9, 2020, and the Form 483 is dated October 9, 2020.
How do I get the full Form 483 for Millers of Wyckoff, 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.