Montana Compounding Pharmacy and Wellness Center
Form 483 issued May 15, 2015 · Houston, Texas
- Inspection
- May 5 – May 15, 2015
- Investigators
- Margaret M. Annes· Patty P. Kaewussdangkul
- Observations
- 12
- Pages
- 8
- FEI number
- 3011501377
In short: On May 15, 2015, FDA issued a Form 483 with 12 observations to Montana Compounding Pharmacy and Wellness Center in Houston, Texas (FEI 3011501377) after an inspection that ran May 5 – May 15, 2015. The investigators were Margaret M. Annes and Patty P. Kaewussdangkul. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.188 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records are not prepared for each batch of drug product produced and…
- 02
Records fail to include an individual inventory record of each component and the reconciliation of the…
- 03
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 04
Batch production and control records do not include the identification of the persons performing and checking…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmMontana Compounding Pharmacy and Wellness Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Montana Compounding Pharmacy and Wellness Center?
FDA listed 12 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Montana Compounding Pharmacy and Wellness Center?
Margaret M. Annes and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of May 5 – May 15, 2015. Each investigator has a profile showing what they cite most.
When was Montana Compounding Pharmacy and Wellness Center inspected by FDA?
The inspection ran May 5 – May 15, 2015, and the Form 483 is dated May 15, 2015.
How do I get the full Form 483 for Montana Compounding Pharmacy and Wellness Center?
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.