Phillips Precision, Inc
FDA inspection history in Elmwood Park, New Jersey, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Elmwood Park, New Jersey.
Cited most
Across all Phillips Precision observations on file
- 21 CFR 820.70(e)Production and process controls2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.80(a)Receiving, in-process, and finished device acceptance1
The complete Phillips Precision file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Elmwood Park, New Jersey
One warning letter and one Form 483 · 2024 · 8 observations
Latest: Warning letter, Dec 9, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-09 | Warning letter Warning letter | Elmwood Park, New Jersey | — | $99 |
| 2024-07-17 | 483 Form 483 | Elmwood Park, New Jersey | 8 | $99 |
Investigators on these documents
FEI number 3003387384 · most recent document Dec 9, 2024
About Phillips Precision, Inc
How many FDA Form 483s has Phillips Precision, Inc received?
FDA Intel has 1 Form 483 on file for Phillips Precision, Inc; the most recent is dated Jul 17, 2024.
When was Phillips Precision, Inc last inspected by FDA?
The most recent FDA inspection document on file for Phillips Precision, Inc is a Form 483 dated Jul 17, 2024, for the site in Elmwood Park, New Jersey.
What did FDA cite at Phillips Precision, Inc?
The regulations cited most in the observations on file for Phillips Precision, Inc are 21 CFR 820.70(e) (Production and process controls), 2 times; 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Phillips Precision, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Phillips Precision, Inc; the most recent is dated Dec 9, 2024.