Ampharmco, LLC
Form 483 issued March 27, 2019 · Fort Worth, Texas
- Inspection
- Mar 20 – Mar 27, 2019
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 3
- FEI number
- 3002668504
In short: On March 27, 2019, FDA issued a Form 483 with 2 observations to Ampharmco, LLC in Fort Worth, Texas (FEI 3002668504) after an inspection that ran Mar 20 – Mar 27, 2019. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(3) (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAmpharmco, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ampharmco, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Ampharmco, LLC?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Mar 20 – Mar 27, 2019. Each investigator has a profile showing what they cite most.
When was Ampharmco, LLC inspected by FDA?
The inspection ran Mar 20 – Mar 27, 2019, and the Form 483 is dated March 27, 2019.
How do I get the full Form 483 for Ampharmco, LLC?
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.