Millers of Wyckoff, Inc.
Form 483 issued July 16, 2015 · Wyckoff, New Jersey
- Inspection
- Jun 29 – Jul 16, 2015
- Investigator
- Susan M. Joseph
- Observations
- 12
- Pages
- 5
- FEI number
- 3004600183
In short: On July 16, 2015, FDA issued a Form 483 with 12 observations to Millers of Wyckoff, Inc. in Wyckoff, New Jersey (FEI 3004600183) after an inspection that ran Jun 29 – Jul 16, 2015. The investigator was Susan M. Joseph. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
This inspection in context
Susan M. Joseph
1 document · 2015
Cites 211.42(b) (design and construction features) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Millers of Wyckoff, Inc.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Millers of Wyckoff, Inc.?
Susan M. Joseph is named on this Form 483, for the inspection of Jun 29 – Jul 16, 2015. Each investigator has a profile showing what they cite most.
When was Millers of Wyckoff, Inc. inspected by FDA?
The inspection ran Jun 29 – Jul 16, 2015, and the Form 483 is dated July 16, 2015.
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.