Mission Pharmacal Company
Form 483 issued September 22, 2022 · Boerne, Texas
- Inspection
- Sep 19 – Sep 22, 2022
- Investigator
- Michelle A. Krayer
- Observations
- 2
- Pages
- 3
- FEI number
- 3000204446
In short: On September 22, 2022, FDA issued a Form 483 with 2 observations to Mission Pharmacal Company in Boerne, Texas (FEI 3000204446) after an inspection that ran Sep 19 – Sep 22, 2022. The investigator was Michelle A. Krayer. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.56(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 02
Written records are not always made of…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) 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 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mission Pharmacal Company?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Mission Pharmacal Company?
Michelle A. Krayer is named on this Form 483, for the inspection of Sep 19 – Sep 22, 2022. Each investigator has a profile showing what they cite most.
When was Mission Pharmacal Company inspected by FDA?
The inspection ran Sep 19 – Sep 22, 2022, and the Form 483 is dated September 22, 2022.
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.