Allermed Laboratories, Inc.
Form 483 issued June 14, 2017 · San Diego, California
- Inspection
- Jun 7 – Jun 14, 2017
- Investigator
- Simone E. Pitts
- Observations
- 3
- Pages
- 3
- FEI number
- 1000098920
In short: On June 14, 2017, FDA issued a Form 483 with 3 observations to Allermed Laboratories, Inc. in San Diego, California (FEI 1000098920) after an inspection that ran Jun 7 – Jun 14, 2017. The investigator was Simone E. Pitts. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Standard Operating Procedure Document #313-000 titled Microbial Monitoring of Cleanroom Personnel is silent with respect to…
- 03
Media Fills to quality the aseptic simulation process for standardized and non- standardized products is deficient…
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
The firmAllermed 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 Allermed Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about production. 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 Allermed Laboratories, Inc.?
Simone E. Pitts is named on this Form 483, for the inspection of Jun 7 – Jun 14, 2017. Each investigator has a profile showing what they cite most.
When was Allermed Laboratories, Inc. inspected by FDA?
The inspection ran Jun 7 – Jun 14, 2017, and the Form 483 is dated June 14, 2017.
How do I get the full Form 483 for Allermed 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.