Mission Pharmacal Company
Form 483 issued April 4, 2019 · Boerne, Texas
- Inspection
- May 25, 2012 – Apr 4, 2019
- Investigator
- Lucas B. Leake
- Observations
- 6
- Pages
- 12
- FEI number
- 3000204446
In short: On April 4, 2019, FDA issued a Form 483 with 6 observations to Mission Pharmacal Company in Boerne, Texas (FEI 3000204446) after an inspection that ran May 25, 2012 – Apr 4, 2019. The investigator was Lucas B. Leake. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.110 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aa NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
A written record of each complaint is not maintained in a file designated for drug product…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Lucas B. Leake
8 documents · 2012–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmMission Pharmacal Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mission Pharmacal Company?
FDA listed 6 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Mission Pharmacal Company?
Lucas B. Leake is named on this Form 483, for the inspection of May 25, 2012 – Apr 4, 2019. Each investigator has a profile showing what they cite most.
When was Mission Pharmacal Company inspected by FDA?
The inspection ran May 25, 2012 – Apr 4, 2019, and the Form 483 is dated April 4, 2019.
How do I get the full Form 483 for Mission Pharmacal Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.