Drug factory · FDA FEI 3004395604

Aquestive Therapeutics

6465 Ameriplex Drive, Portage, IN, United States

Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2025.

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

6 drug inspections on record since 2008: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Buprenorphine and Naloxone	Makes it, tests it and packages it	Indivior Inc.	12496-1202, 12496-1204, 12496-1208 +1

Ended	Result	Program	Problems noted
Jan 30, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 3, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	4
Sep 13, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jun 28, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 23, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 23, 2008	Problems found, fixed voluntarily	Drug Quality Assurance	4

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

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Weight or measure of sample 21 CFR 211.194(a)(3)
Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate.
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.
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.

Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
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.
Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
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.

Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
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.
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.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; distribute; label; manufacture; pack; relabel; repack.