Drug factory · FDA FEI 3006503102

Pharmaceutics International, Inc.

103 Beaver Court, Cockeysville, MD, United States

Serious problems, FDA action at FDA's last inspection, Mar 6, 2026.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

10 drug inspections on record since 2013: 1 with no problems, 7 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Aprepitant	Makes it	Spes Pharmaceuticals Inc.	82243-1001
Nitrite Ion	Makes it	Hope Pharmaceuticals	60267-311
Thiosulfate Ion	Makes it	Hope Pharmaceuticals	60267-705

FDA inspection history

Ended	Result	Program	Problems noted
Mar 6, 2026	Serious problems, FDA action	Drug Quality Assurance	9
Nov 14, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 29, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 10, 2020	No problems found	Drug Quality Assurance	—
Nov 9, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 27, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 4, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 29, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 17, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 13, 2013	Serious problems, FDA action	Drug Quality Assurance	—

What inspectors wrote down

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

Mar 6, 2026 inspection

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written standards are not recorded.
Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch.
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.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established 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; manufacture.