Drug factory · FDA FEI 1000136461

Digestive Care, Inc.

1120 Win Dr., Bethlehem, PA, United States

Problems found, fixed voluntarily at FDA's last inspection, May 5, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Pancrelipase Amylase and Pancrelipase Lipase and Pancrelipase Protease	Makes it	Digestive Care, Inc.	59767-004, 59767-008, 59767-016 +1

Ended	Result	Program	Problems noted
May 5, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jun 27, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jul 27, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	3
Sep 25, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 2, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 11, 2010	No problems found	Drug Quality Assurance	—
Jul 22, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Deviations of production time limits 21 CFR 211.111
Deviations from production time limits are not justified and compromise the quality of the drug product.

Registered with FDA for: analysis; manufacture; pack.