Millers of Wyckoff, Inc.
FDA inspection history across 2 sites, 2015 to 2021
- 3
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2019: one close-out letter; 2020: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–21Three Form 483s, two warning letters and one close-out letter, at Wyckoff, New Jersey and New Jersey.
- 2015The longest 483 on file: 12 observations over 5 pages at Wyckoff, New Jersey.
Cited most
Across all Millers of Wyckoff observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42(b)Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.165(a)Testing and release for distribution1
The complete Millers of Wyckoff file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Wyckoff, New Jersey
Three Form 483s, one close-out letter and one warning letter · 2015 to 2020 · 20 observations
Latest: Form 483, Oct 9, 2020 →New Jersey
One warning letter · 2021
Latest: Warning letter, Dec 1, 2021 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-01 | Warning letter Warning letter | New Jersey | — | $99 |
| 2020-10-09 | 483 Form 483 | Wyckoff, New Jersey | 2 | $99 |
| 2019-02-26 | Close-out Close-out letter | Wyckoff, New Jersey | — | $99 |
| 2017-05-18 | 483 Form 483 | Wyckoff, New Jersey | 6 | $99 |
| 2016-06-07 | Warning letter Warning letter | Wyckoff, New Jersey | — | $99 |
| 2015-07-16 | 483 Form 483 | Wyckoff, New Jersey | 12 | $99 |
Investigators on these documents
Nancy F. Scheraga (1)Susan M. Joseph (1)Tonia F. Bernard (1)
FEI number 3004600183 · most recent document Dec 1, 2021
About Millers of Wyckoff, Inc.
How many FDA Form 483s has Millers of Wyckoff, Inc. received?
FDA Intel has 3 Form 483s on file for Millers of Wyckoff, Inc.; the most recent is dated Oct 9, 2020.
When was Millers of Wyckoff, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Millers of Wyckoff, Inc. is a Form 483 dated Oct 9, 2020, for the site in Wyckoff, New Jersey.
What did FDA cite at Millers of Wyckoff, Inc.?
The regulations cited most in the observations on file for Millers of Wyckoff, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42(b) (Design and construction features), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Millers of Wyckoff, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Millers of Wyckoff, Inc.; the most recent is dated Dec 1, 2021.