Homeocare Laboratories
FDA inspection history in Yonkers, New York, 2017 to 2024
- 4
- Form 483s
- 2
- Close-outs
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2017: one warning letter; 2018: one close-out letter; 2019: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–24Four Form 483s, two close-out letters and one warning letter, at Yonkers, New York.
- 2024The longest 483 on file: 12 observations over 12 pages at Yonkers, New York.
Cited most
Across all Homeocare Laboratories observations on file
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.166Stability testing4
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.160(b)General requirements2
The complete Homeocare Laboratories file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Yonkers, New York
Four Form 483s, two close-out letters and one warning letter · 2017 to 2024 · 37 observations
Latest: Form 483, Mar 20, 2024 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-20 | 483 Form 483 | Yonkers, New York | 12 | $99 |
| 2023-02-21 | 483 Form 483 | Yonkers, New York | 10 | $99 |
| 2021-06-04 | 483 Form 483 | Yonkers, New York | 9 | $99 |
| 2020-06-22 | Close-out Close-out letter | Yonkers, New York | — | $99 |
| 2019-12-13 | 483 Form 483 | Yonkers, New York | 6 | $99 |
| 2018-06-25 | Close-out Close-out letter | Yonkers, New York | — | $99 |
| 2017-09-07 | Warning letter Warning letter | Yonkers, New York | — | $99 |
Investigators on these documents
Anastasia M. Shields (1)Erik W. Koester (1)Jonathan G. Matrisciano (1)Raihan A. Chowdhury (1)Tanya R. Syffrard (1)Terry Bridgewater (1)Vivin George (1)
FEI number 3008420443 · most recent document Mar 20, 2024
About Homeocare Laboratories
How many FDA Form 483s has Homeocare Laboratories received?
FDA Intel has 4 Form 483s on file for Homeocare Laboratories; the most recent is dated Mar 20, 2024.
When was Homeocare Laboratories last inspected by FDA?
The most recent FDA inspection document on file for Homeocare Laboratories is a Form 483 dated Mar 20, 2024, for the site in Yonkers, New York.
What did FDA cite at Homeocare Laboratories?
The regulations cited most in the observations on file for Homeocare Laboratories are 21 CFR 211.67 (Equipment cleaning and maintenance), 6 times; 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.166 (Stability testing), 4 times.
Has Homeocare Laboratories received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Homeocare Laboratories; the most recent is dated Sep 7, 2017.