Drug factory · FDA FEI 1628114
DPT Laboratories, Ltd.
307 E. Josephine Street, San Antonio, TX, United States
No problems found at FDA's last inspection, May 29, 2024.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2009: 6 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 29, 2024 | No problems found | Drug Quality Assurance | — |
| May 5, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 23, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 31, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 27, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 12, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 2, 2009 | No problems found | 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.
Dec 14, 2018 inspection
- Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs. - Identification of Equipment and Lines 21 CFR 211.188(b)(2)
The batch production and control records are deficient in that they do not include the identity of major equipment used. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred.
Nov 12, 2010 inspection
- Sampling and testing plans not followed 21 CFR 211.165(c)
Written procedures for sampling and testing plans are not followed for each drug product. - 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.
Registered with FDA for: analysis; label; manufacture; pack.