Colonia Care Pharmacy
FDA inspection history in Colonia, New Jersey, 2016 to 2021
- 3
- Form 483s
- 2
- Responses
- 1
- Warning letter
Every document, by year
- Response
- Form 483
- Warning letter
2016: one 483 response and one Form 483; 2017: one warning letter; 2019: one Form 483; 2021: one 483 response and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–21Three Form 483s, two 483 responses and one warning letter, at Colonia, New Jersey.
- 2016The longest 483 on file: 5 observations over 4 pages at Colonia, New Jersey.
Cited most
Across all Colonia Care Pharmacy observations on file
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
The complete Colonia Care Pharmacy file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Colonia, New Jersey
Three Form 483s, one 483 response and one warning letter · 2016 to 2021 · 11 observations
Latest: Response, Aug 17, 2021 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-17 | Response 483 response | Colonia, New Jersey | — | $199 |
| 2021-07-26 | 483 Form 483 | Colonia, New Jersey | 3 | $99 |
| 2019-04-22 | 483 Form 483 | Colonia, New Jersey | 3 | $99 |
| 2017-10-12 | Warning letter Warning letter | Colonia, New Jersey | — | $99 |
| 2016-05-05 | Response 483 response | — | — | $199 |
| 2016-04-15 | 483 Form 483 | Colonia, New Jersey | 5 | $99 |
Investigators on these documents
B. M. Mveng (1)Jessica S. Estriplet (1)Nicholas Violand (1)Nicolas A. Violand (1)Unnee Ranjan (1)
FEI number 3012223534 · most recent document Aug 17, 2021
About Colonia Care Pharmacy
How many FDA Form 483s has Colonia Care Pharmacy received?
FDA Intel has 3 Form 483s on file for Colonia Care Pharmacy; the most recent is dated Jul 26, 2021.
When was Colonia Care Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Colonia Care Pharmacy is a Form 483 dated Jul 26, 2021, for the site in Colonia, New Jersey.
What did FDA cite at Colonia Care Pharmacy?
The regulations cited most in the observations on file for Colonia Care Pharmacy are FDCA 501(a)(2)(A) (Insanitary conditions), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has Colonia Care Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Colonia Care Pharmacy; the most recent is dated Oct 12, 2017.