Drug factory · FDA FEI 3003194366

ChiRhoClin, Inc

4000 Blackburn Lane Suite 270, Burtonsville, MD, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 15, 2025.

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: 2 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Secretin Human	Makes it	ChiRhoClin, Inc.	67066-007

Ended	Result	Program	Problems noted
Sep 15, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	8
Nov 3, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	6
May 30, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	1
Sep 7, 2012	No problems found	Drug Quality Assurance	—
Sep 7, 2012	No problems found	Bioresearch Monitoring	—
Apr 3, 2012	Serious problems, FDA action	Drug Quality Assurance	—
May 26, 2009	Problems found, fixed voluntarily	Bioresearch Monitoring	—

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

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed.
Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products.
Representative Number of Batches for Annual Review 21 CFR 211.180(e)(1)
The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of approved and rejected batches.
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.
Comparison of Test Results to Specifications 21 CFR 211.194(a)(6)
Laboratory records are deficient in that they do not include a statement of the results of tests and how they compare to the established specifications.
Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to supervise the manufacture, processing, packing and holding of each drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Registered with FDA for: manufacture.