Millers of Wyckoff, Inc.
Form 483 issued May 18, 2017 · Wyckoff, New Jersey
- Inspection
- May 18, 2017
- Investigator
- Nancy F. Scheraga
- Observations
- 6
- Pages
- 4
- FEI number
- 3004600183
In short: On May 18, 2017, FDA issued a Form 483 with 6 observations to Millers of Wyckoff, Inc. in Wyckoff, New Jersey (FEI 3004600183) after an inspection that ran May 18, 2017. The investigator was Nancy F. Scheraga. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 2 systems, led by materials.
Most cited: 21 CFR 211.84 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The identity of each component of a drug product is not verified by conducting at least…
- 06
The firm's use of disinfecting agents in the cleanroom and ISO 5 areas…
This inspection in context
Nancy F. Scheraga
9 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Millers of Wyckoff, Inc.?
FDA listed 6 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Millers of Wyckoff, Inc.?
Nancy F. Scheraga is named on this Form 483, for the inspection of May 18, 2017. Each investigator has a profile showing what they cite most.
When was Millers of Wyckoff, Inc. inspected by FDA?
The inspection ran May 18, 2017, and the Form 483 is dated May 18, 2017.
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.