Digestive Care, Inc.
Form 483 issued June 27, 2023 · Bethlehem, Pennsylvania
- Inspection
- Jun 21 – Jun 27, 2023
- Investigator
- Karen A. Briggs
- Observations
- 1
- Pages
- 3
- FEI number
- 1000136461
In short: On June 27, 2023, FDA issued a Form 483 with 1 observation to Digestive Care, Inc. in Bethlehem, Pennsylvania (FEI 1000136461) after an inspection that ran Jun 21 – Jun 27, 2023. The investigator was Karen A. Briggs. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmDigestive Care, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.142(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Digestive Care, Inc.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Digestive Care, Inc.?
Karen A. Briggs is named on this Form 483, for the inspection of Jun 21 – Jun 27, 2023. Each investigator has a profile showing what they cite most.
When was Digestive Care, Inc. inspected by FDA?
The inspection ran Jun 21 – Jun 27, 2023, and the Form 483 is dated June 27, 2023.
How do I get the full Form 483 for Digestive Care, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.