Drug factory · FDA FEI 3000204446
Mission Pharmacal Company
38505 IH 10 West, Boerne, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 22, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 6 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 4, 2017 | No problems found | Drug Quality Assurance | — |
| May 4, 2017 | No problems found | Bioresearch Monitoring | — |
| Feb 7, 2014 | No problems found | Drug Quality Assurance | 2 |
| Feb 7, 2014 | No problems found | Bioresearch Monitoring | 2 |
| May 25, 2012 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Mar 12, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 12, 2010 | No problems found | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 22, 2022 inspection
- No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - 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 free of infestation by rodents, birds insects, and other vermin.
Feb 7, 2014 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls and tests to be conducted on appropriate samples of in-process materials of each batch. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls and tests to be conducted on appropriate samples of in-process materials of each batch.
May 25, 2012 inspection
- 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. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls and tests to be conducted on appropriate samples of in-process materials of each batch. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Written complaint record to be maintained at facility 21 CFR 211.198(b)
A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed. - 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. - Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
Registered with FDA for: analysis; label; manufacture; pack.