Digestive Care Inc
Form 483 issued July 27, 2018 · rem, Pennsylvania
- Investigator
- David A. Oluwo
- Observations
- 1
- Pages
- 3
In short: On July 27, 2018, FDA issued a Form 483 with 1 observation to Digestive Care Inc in rem, Pennsylvania. The investigator was David A. Oluwo. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
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
The site's inspection history, in date order.
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). 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. Each investigator has a profile showing what they cite most.
When was Digestive Care Inc inspected by FDA?
This 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.