Allergy Laboratories, Inc.
Form 483 issued April 26, 2013 · Oklahoma City, Oklahoma
- Inspection
- Apr 16 – Apr 26, 2013
- Investigators
- Mihaly S. Ligmond· Paula A. Trost
- Observations
- 29
- Pages
- 19
- FEI number
- 1621802
In short: On April 26, 2013, FDA issued a Form 483 with 29 observations to Allergy Laboratories, Inc. in Oklahoma City, Oklahoma (FEI 1621802) after an inspection that ran Apr 16 – Apr 26, 2013. The investigators were Mihaly S. Ligmond and Paula A. Trost. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 21 of 29 observations.
Most cited: 21 CFR 211.113 (10×) · 211.192 (7×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of assurance in the environmental quality in Class 100 aseptic processing areas…
- 02
SOP QC-033.00, Facility Bioburden, section 9.1.3 requires that "All environmental isolates are sent out for identification…
- 03
Since 11/5/12 the firm has experienced sterility failures for 9 commercial products. The investigations into 5…
- 04
Actions taken regarding non-viable particulate excursions that occur during aseptic…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmAllergy Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergy Laboratories, Inc.?
FDA listed 29 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Allergy Laboratories, Inc.?
Mihaly S. Ligmond and Paula A. Trost are named on this Form 483, for the inspection of Apr 16 – Apr 26, 2013. Each investigator has a profile showing what they cite most.
When was Allergy Laboratories, Inc. inspected by FDA?
The inspection ran Apr 16 – Apr 26, 2013, and the Form 483 is dated April 26, 2013.
How do I get the full Form 483 for Allergy Laboratories, Inc.?
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.