Enclara Pharmacia Inc.
FDA inspection history across 2 sites, 2016 to 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483 and one warning letter, at Shar on Hill, Pennsylvania and Sharon Hill, Pennsylvania.
Cited most
Across all Enclara Pharmacia observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Enclara Pharmacia file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sharon Hill, Pennsylvania
One warning letter · 2017
Latest: Warning letter, Mar 29, 2017 →Shar on Hill, Pennsylvania
One Form 483 · 2016 · 3 observations
Latest: Form 483, Jun 6, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-29 | Warning letter Warning letter | Sharon Hill, Pennsylvania | — | $99 |
| 2016-06-06 | 483 Form 483 | Shar on Hill, Pennsylvania | 3 | $99 |
Investigators on these documents
FEI number 3012188803 · most recent document Mar 29, 2017
About Enclara Pharmacia Inc.
How many FDA Form 483s has Enclara Pharmacia Inc. received?
FDA Intel has 1 Form 483 on file for Enclara Pharmacia Inc.; the most recent is dated Jun 6, 2016.
When was Enclara Pharmacia Inc. last inspected by FDA?
The most recent FDA inspection document on file for Enclara Pharmacia Inc. is a Form 483 dated Jun 6, 2016, for the site in Shar on Hill, Pennsylvania.
What did FDA cite at Enclara Pharmacia Inc.?
The regulations cited most in the observations on file for Enclara Pharmacia Inc. are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times; 21 CFR 211.28(a) (Personnel responsibilities), 1 time.
Has Enclara Pharmacia Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Enclara Pharmacia Inc.; the most recent is dated Mar 29, 2017.