Purac America, Inc.
Form 483 issued August 2, 2024 · Tucker, Georgia
- Observations
- 5
- Pages
- 7
- FEI number
- 3016432787
In short: On August 2, 2024, FDA issued a Form 483 with 5 observations to Purac America, Inc. in Tucker, Georgia (FEI 3016432787). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 04
The separate or defined areas and control systems necessary to prevent contamination…
This inspection in context
Questions about this 483
What did FDA find at Purac America, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Purac America, Inc. inspected by FDA?
This Form 483 is dated August 2, 2024.
How do I get the full Form 483 for Purac America, 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.