Digestive Care, Inc.
FDA inspection history in Bethlehem, Pennsylvania, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Bethlehem, Pennsylvania.
- 2018The longest 483 on file: 3 observations over 3 pages at Bethlehem, Pennsylvania.
- 2023One Form 483, at Bethlehem, Pennsylvania.
Cited most
Across all Digestive Care observations on file
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
- 21 CFR 314.81(b)(1)(ii)Other postmarketing reports1
The complete Digestive Care 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
Bethlehem, Pennsylvania
Two Form 483s · 2018 to 2023 · 4 observations
Latest: Form 483, Jun 27, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-27 | 483 Form 483 | Bethlehem, Pennsylvania | 1 | $99 |
| 2018-07-27 | 483 Form 483 | Bethlehem, Pennsylvania | 3 | $99 |
Investigators on these documents
FEI number 1000136461 · most recent document Jun 27, 2023
About Digestive Care, Inc.
How many FDA Form 483s has Digestive Care, Inc. received?
FDA Intel has 2 Form 483s on file for Digestive Care, Inc.; the most recent is dated Jun 27, 2023.
When was Digestive Care, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Digestive Care, Inc. is a Form 483 dated Jun 27, 2023, for the site in Bethlehem, Pennsylvania.
What did FDA cite at Digestive Care, Inc.?
The regulations cited most in the observations on file for Digestive Care, Inc. are 21 CFR 211.142(b) (Warehousing procedures), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 1 time.