Digestive Care, Inc.
Form 483 issued July 27, 2018 · Bethlehem, Pennsylvania
- Inspection
- Jul 16 – Jul 27, 2018
- Investigator
- David A. Oluwo
- Observations
- 3
- Pages
- 3
- FEI number
- 1000136461
In short: On July 27, 2018, FDA issued a Form 483 with 3 observations to Digestive Care, Inc. in Bethlehem, Pennsylvania (FEI 1000136461) after an inspection that ran Jul 16 – Jul 27, 2018. The investigator was David A. Oluwo. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Digestive Care, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Digestive Care, Inc.?
David A. Oluwo is named on this Form 483, for the inspection of Jul 16 – Jul 27, 2018. Each investigator has a profile showing what they cite most.
When was Digestive Care, Inc. inspected by FDA?
The inspection ran Jul 16 – Jul 27, 2018, and the Form 483 is dated July 27, 2018.
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.