Drug factory · FDA FEI 3003197096

TriRx Huntsville Pharmaceutical Services, LLC

120 Vintage Dr, Huntsville, AL, United States

No problems found at FDA's last inspection, Aug 11, 2023.

No Action Indicated: inspectors found no objectionable conditions.

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

What it does, for whom

Drug	Role	For	NDC
Acetaminophen and Hydrocodone	Makes it, packages it and labels it	Genus Lifesciences Inc.	64950-343
Chlorpromazine	Makes it, packages it and labels it	Saptalis Pharmaceuticals, LLC.	71656-101, 71656-102
Clindamycin	Makes it, tests it and packages it	i3 Pharmaceuticals, LLC	72319-696
Dextromethorphan and Promethazine	Makes it	Slate Run Pharmaceuticals, LLC.	70436-155
Nystatin	Makes it, tests it, packages it and labels it	Genus Lifesciences Inc.	64950-372
Sucralfate	Makes it, tests it and packages it	Richmond Pharmaceuticals, Inc., Torrent Pharma, Inc., TruPharma LLC.	54738-005, 13668-754, 52817-840
Sulfamethoxazole and Trimethoprim	Makes it, packages it and labels it	Pharmaceutical Associates, Inc.	0121-0853

Ended	Result	Program	Problems noted
Aug 11, 2023	No problems found	Drug Quality Assurance	—
Apr 1, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 21, 2016	No problems found	Drug Quality Assurance	—
Dec 19, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 17, 2014	No problems found	Unapproved and Misbranded Drugs	—
May 30, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 21, 2013	No problems found	Drug Quality Assurance	—
Dec 7, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 14, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	3
Dec 10, 2010	No problems found	Drug Quality Assurance	—
Mar 19, 2010	No problems found	Drug Quality Assurance	—
Aug 21, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the storage of components.

Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

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