Drug factory · FDA FEI 1000117684

DPT Laboratories, Ltd.

5303 Distribution Drive, San Antonio, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 10, 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: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Feb 10, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 23, 2019	No problems found	Drug Quality Assurance	—
Aug 26, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 25, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	7
Aug 2, 2013	No problems found	Drug Quality Assurance	—
Nov 12, 2010	No problems found	Drug Quality Assurance	—
Jul 2, 2009	No problems found	Drug Quality Assurance	—

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

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.
Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and 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.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Written procedures describing in detail 21 CFR 211.122(a)
There is a lack of written procedures describing in sufficient detail the receipt, storage, and handling of labeling and packaging materials.
Written procedures not followed 21 CFR 211.122(a)
Written procedures for the receipt, storage, and handling of packaging and labeling materials are not followed.
Label storage access limited to authorized personnel 21 CFR 211.122(d)
Access to the storage area for labels and labeling materials is not limited to authorized personnel.
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.
No written record of investigation 21 CFR 211.192
Written records are not made of investigations into unexplained discrepancies.
Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination.

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